Method incorporating computer-implemented steps, a computing device, a computer readable storage medium, and a client computing device for modelling the alignment of an orthopaedic implant for a joint of a patient

ABSTRACT

The present disclosure relates to a method incorporating computer-implemented steps, a computing device, a computer readable storage medium, and a client computing device for modelling the alignment of an orthopaedic implant for a joint of a patient. The method comprises the computer-implemented steps of being responsive to patient specific information data for deriving patient data, where the patient specific information data is indicative of one or more dynamic characteristics, and being responsive to the patient data for providing 3D model data of the joint, such that the 3D model data shows the orthopaedic implant in an alignment configuration based on the patient specific information data.

RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.14/000,858 filed on Aug. 21, 2013 and entitled A COMPUTER-IMPLEMENTEDMETHOD, A COMPUTING DEVICE AND A COMPUTER READABLE STORAGE MEDIUM FORPROVIDING ALIGNMENT INFORMATION DATA FOR THE ALIGNMENT OF AN ORTHOPAEDICIMPLANT FOR A JOINT OF A PATIENT which is the National Stage ofInternational PCT/AU2012/000179, filed on Feb. 24, 2012 which claims thebenefit of Foreign Patent Application AU 2011900673, filed on Feb. 25,2011, the disclosure of which is incorporated by reference herein.

FIELD OF THE INVENTION

The present invention relates to a method comprisingcomputer-implemented steps, a computing device, a computer readablestorage medium, and a client computing device for providing alignmentinformation data for modelling the alignment of an orthopaedic implantfor a joint of a patient.

The invention has been developed primarily for use in modelling thealignment of an orthopaedic implant for a knee or hip joint of apatient, and providing tools for assisting with the modelling of thealignment of an orthopaedic implant for a knee or hip joint of apatient, and will be described hereinafter with reference to thisapplication. However, it will be appreciated that the invention is notlimited to this particular field of use.

BACKGROUND OF THE INVENTION

Replacing joints with orthopaedic implants due to injury or degenerationhas been commonplace for many years. A more fitness-driven outlook andactive lifestyle pursued by the older generation is giving rise to anincreasing frequency of joint degeneration or injury from an earlierage.

As such, joints, such as knee and hip joints, must be surgicallyrepaired or, in some cases, totally replaced. The current method forreplacing joints typically involves mechanical axis alignment of a jointfor placing the orthopaedic implant. This involves taking a number ofstationary physical measurements to align the orthopaedic implant to thepatient's primary mechanical weight bearing axis. For example, for aknee joint, this involves aligning the orthopaedic implant based on amechanical weight bearing axis that intersects the centre of the hip,the centre of the knee and the centre of the ankle.

Current standard surgical practice is to use instruments (mechanical andcomputer driven) to align implants to reference points. The mechanicalaxis in knees and an analogous geometrical reference frame in hips isused (for example, 45 degrees cup inclination, 15 to 20 degrees cupante-version, neutral femoral stem position).

It is also known to try to adjust the range of motion of the joint byvarying the implant position. This is either done manually, through theexpert handling/feel of the surgeon, or, through the computedidentification of a central axis of the range of motion.

It is also noted that commercially available computer navigation systemscurrently provide information about mechanical alignment and the abilityto customize implant position from this information.

Total joint replacements that are aligned using mechanical axisalignment, although showing favourable results for survivorship andlongevity, are often disappointing when measured in terms of functionalpatient outcomes. That is, the joints are not suited to activities thata person may wish to undertake, therefore causing pain and discomfort tothe person. In some cases, such activities will cause the implant tofail.

People with total joint replacements rarely achieve the lifestyleequivalents of their non-arthritic peers. As such, there is a lack oftechniques that demonstrate improvements in patient function and qualityof life, after a total joint replacement.

The problems mentioned above can be attributed to the lack of patientspecificity offered by ‘off the shelf’ orthopaedic implant designs. Allpatients receive the same implant designs in the same positionregardless of their age, gender, activity level or body shape. However,not all patients are the same.

Patient diversity has recently received much attention within theorthopaedic literature. A topical example is the difference in the sizeof male and female knees. This has led total knee replacement (TKR)manufacturers to introduce separate size ranges for male and femaleimplants.

This only goes some of the way to addressing the diversity encounteredby orthopaedic surgeons in practice today. Many published studieshighlight many more morphological differences that exist within sampledpatient populations.

A pertinent example is that of the slope of patients' tibial plateaus.Males have been measured on average to have significantly differentposterior slopes to that measured in females. Furthermore, there hasbeen significant inter-sex variation observed. Yet manufacturersrecommend to surgeons implanting knee replacements that they align thetibial components with a one size fits all ‘standard’ recommendedprostheses alignment. This alignment recommendation does not change ifyou are male or female, whether you have a severe tibial slope or a mildtibial slope, whether you are short or tall, or whether you have a highor low demand lifestyle.

This is not just the case for tibial component alignment. All of thealignment parameters generally recommended to surgeons are one size fitsall generalisations. This one size fits approach to TKR surgerycontributes to the relatively poor functional outcomes.

Similar generalisations can be found in the hip replacement arena. The‘gold standard’ acetabular cup position for all patients is defined tobe forty-five degrees of inclination and twenty degrees of ante versionwith reference to the anterior pelvic plane. This standard alignmentbecomes inappropriate when a patient presents with an anatomicalvariation, such as, pelvic tilt, pelvic mobility or pelvic stiffness.

Examples of processes for achieving mechanical axis alignment in totalknee replacement surgery using imaging data and rapid prototypemanufacturing techniques include: Prophecy™ (Wright Medical Technology,Inc.), Trumatch™ (DePuy Orthopaedics, Inc. a Johnson & Johnson Company),Signature™ Personalized Total Knee Replacement (Biomet, Inc.), MyKnee™(Medacta, International SA), Zimmer™ Patient Specific Instruments(Zimmer, Inc.), Otis Knee™ (OtisMed, Corp.), and Visionaire™ (Smith &Nephew, Inc.), amongst others.

Examples of processes for achieving mechanical axis alignment in totalknee replacement surgery using computer navigation software include:eNact Knee Navigation System™ (Stryker) and BrainLab™ Knee Navigation(BrainLab, Inc.).

Examples of processes for achieving mechanical axis alignment in totalknee replacement surgery using robotics systems include: MAKOplasty™Partial Knee Resurfacing (Mako Surgical Corp.).

However, as with known alignment processes, there is no factoring intothe processing of, amongst others, age, gender, activity level or bodyshape which ultimately will have an effect on how a person will respondto a particular alignment.

The present invention seeks to provide a computer-implemented method, acomputing device, and a computer readable storage medium for providingalignment information data for the alignment of an orthopaedic implantfor a joint of a patient, which will overcome or substantiallyameliorate at least some of the deficiencies of the prior art, or to atleast provide an alternative.

It is to be understood that, if any prior art information is referred toherein, such reference does not constitute an admission that theinformation forms part of the common general knowledge in the art, inAustralia or any other country.

SUMMARY OF THE INVENTION

According to one aspect of the present invention, there is provided acomputer-implemented method for providing alignment information data forthe alignment of an orthopaedic implant for a joint of a patient, thecomputer-implemented method comprising the steps of:

-   -   being responsive to patient specific information data for        deriving patient data, the patient specific information data        being indicative of one or more dynamic characteristics; and    -   being responsive to the patient data for providing the alignment        information data for the alignment of the orthopaedic implant.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint according to alignment information data specific tothe patient.

Preferably, the alignment information data comprises actual 3D modeldata of the joint.

Advantageously, the alignment information data comprising 3D model dataof the patient's joint ensures accurate alignment of the orthopaedicimplant to fit the joint.

Preferably, the alignment information data comprises one or more of:location information data for the orthopaedic implant; and orientationinformation data for the orthopaedic implant.

Advantageously, the alignment information data comprising locationinformation data and orientation information data for the orthopaedicimplant, ensures that the orthopaedic implant can be accurately locatedand oriented relative to the patient's joint.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint to enable the patient to form one or more desiredpost-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of the virtual prediction of the jointkinematics data, joint loading data, and joint articulation behaviourdata, thereby enabling the patient to perform the corresponding one ormore desired post-implant activities.

Preferably, the virtual prediction comprises a computer modelprediction.

Advantageously, the virtual prediction of the joint kinematics data,joint loading data, and joint articulation behaviour data is provided asa computer model prediction to predict the performance of theorthopaedic implant for performing the one or more desired post-implantactivities.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information dataspecific to the patient's joint that takes into consideration one ormore static characteristics of the patient's joint.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of a biomechanical reference frame.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information dataspecific to the patient's joint that takes into consideration one ormore load bearing axes of a biomechanical reference frame of thepatient's joint.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information dataspecific to the patient's joint that takes into consideration theprimary load bearing axis of the patient's joint.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration 2D imaging data of the patient's joint.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration 3D imaging data of the patient's joint.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration 4D imaging data of the patient's joint.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration both 2D and 3D imaging data of thepatient's joint.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration one or more physical characteristics ofthe patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer-implemented method further comprises the stepsof:

-   -   determining a set of possible alignment information data        according to the patient data and patient acquired data, the        patient acquired data being indicative of one or more desired        post-implant activities, the patient acquired data comprising        post-implant activities preference data; and    -   selecting the alignment information data from the set of        possible alignment information data according to the        post-implant activities preference data.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration the patient's preference for performingone or more desired post-implant activities.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration comparative patient preference forperforming the one or more desired post-implant activities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   accessing a database of library alignment information data,        wherein the alignment information data is further selected        according to the library alignment information data.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration library alignment information data forperforming the one or more desired post-implant activities.

Preferably, the library alignment information data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration library alignment information data thatrelates to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment information data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint by virtue of deriving alignment information datathat takes into consideration library alignment information data thatrelates to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

According to another aspect of the present invention, there is provideda method of controlling an alignment system to align an orthopaedicimplant according to alignment information data generated by thecomputer-implemented method as defined in any one of the precedingparagraphs.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint using an alignment system according to the alignmentinformation data derived above.

Preferably, the alignment system is selected from a group of alignmentsystems comprising: a robotic alignment system, a haptic feedbackalignment system, and a computer-assisted alignment system.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint using either a robotic alignment system, a hapticfeedback alignment system, or a computer-assisted alignment systemaccording to the alignment information data derived above.

According to another aspect of the present invention, there is provideda computing device for providing alignment information data for thealignment of an orthopaedic implant for a joint of a patient, thecomputing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient specific            information data being indicative of one or more dynamic            characteristics;        -   calculate patient data according to the patient specific            information data; and        -   calculate the alignment information data for the orthopaedic            implant according to the patient data.

Preferably, the alignment information data comprises actual 3D modeldata of the joint.

Preferably, the alignment information data comprises one or more of:location information data for the orthopaedic implant; and orientationinformation data for the orthopaedic implant.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprises a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of a biomechanicalreference frame comprising: an acetabular reference frame, a femoralreference frame, a tibial reference frame, and a spinal reference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the processor is further controlled by the computer programcode to:

-   -   receive, via the data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculate a set of possible alignment information data according        to the patient data and the patient acquired data; and    -   select the alignment information data from the set of possible        alignment information data according to the post-implant        activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computing device further comprises a database forstoring digital data including library alignment information data, thedatabase being coupled to the processor, wherein the processor isfurther controlled by the computer program code to:

-   -   load, from the database, the library alignment information data,        wherein the alignment information data is further selected        according to the library alignment information data.

Preferably, the library alignment information data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment information data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient specific information        data indicative of one or more dynamic characteristics;    -   calculating patient data according to the patient specific        information data; and    -   calculating alignment information data for an orthopaedic        implant according to the patient data.

Preferably, the alignment information data comprises actual 3D modeldata of the joint.

Preferably, the alignment information data comprises one or more of:location information data for the orthopaedic implant; and orientationinformation data for the orthopaedic implant.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of a biomechanicalreference frame comprising: an acetabular reference frame, a femoralreference frame, a tibial reference frame, and a spinal reference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   receiving, via a data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculating a set of possible alignment information data        according to the patient data and the patient acquired data; and    -   selecting the alignment information data from the set of        possible alignment information data according to the        post-implant activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   loading, from a database, library alignment information data,        wherein the alignment information data is further selected        according to the library alignment information data.

Preferably, the library alignment information data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment information data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing device as defined in any one of the preceding paragraphs,wherein the interface is adapted for sending and receiving digital dataas referred to in any one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computer-implemented method for selecting an orthopaedic implant for ajoint of a patient from a group of available orthopaedic implants, thecomputer-implemented method comprising the steps of:

-   -   obtaining alignment information data for a patient according to        the computer-implemented method as defined in any one of the        preceding paragraphs; and    -   being responsive to the alignment information data for selecting        the orthopaedic implant from the group of available orthopaedic        implants.

Advantageously, the orthopaedic implant can be selected from the groupof available orthopaedic implants to fit the patient's joint accordingto the alignment information data specific to the patient.

Preferably, the computer-implemented method further comprises the stepof:

-   -   being responsive to the selected orthopaedic implant for        updating a library alignment information database with the        alignment information data.

Advantageously, the library alignment information database can beupdated with the alignment information data associated with the joint ofthe patient once a suitable orthopaedic implant has been selected fromthe group of available orthopaedic implants to fit the patient's jointaccording to the specific alignment information data.

According to another aspect of the present invention, there is provideda computing device for selecting an orthopaedic implant for a joint of apatient from a group of available orthopaedic implants, the computingdevice comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive alignment information data for a patient according            to the computer-implemented method as defined in any one of            the preceding paragraphs; and        -   select the orthopaedic implant from the group of available            orthopaedic implants according to the alignment information            data.

Preferably, the computing device further comprises a database forstoring digital data including alignment information data, the databasebeing coupled to the processor, wherein the processor is furthercontrolled by the computer program code to:

-   -   update the database with the alignment information data        according to the selected orthopaedic implant.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving alignment information data for a patient according to        the computer-implemented method as defined in any one of the        preceding paragraphs; and    -   selecting an orthopaedic implant from a group of available        orthopaedic implants according to the alignment information        data.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   updating a database with the alignment information data        according to the selected orthopaedic implant.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing device as defined in any one of the preceding paragraphs,wherein the interface is adapted for sending and receiving digital dataas referred to in any one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computer-implemented method for aligning an orthopaedic implant for ajoint of a patient, the computer-implemented method comprising the stepsof:

-   -   obtaining alignment information data according to the        computer-implemented method as defined in any one of the        preceding paragraphs; and    -   being responsive to the alignment information data, causing the        orthopaedic implant to be aligned relative to the joint of the        patient.

Advantageously, the orthopaedic implant can be accurately alignedrelative to the patient's joint according to the obtained alignmentinformation data specific to the patient.

Preferably, the orthopaedic implant is aligned by an alignment systemthat receives the alignment information data.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint using an alignment system according to the alignmentinformation data derived above.

Preferably, the alignment system is selected from a group of alignmentsystems comprising: a robotic alignment system, a haptic feedbackalignment system, and a computer-assisted alignment system.

Advantageously, the orthopaedic implant can be accurately aligned to fitthe patient's joint using either a robotic alignment system, a hapticfeedback alignment system, or a computer-assisted alignment systemaccording to the alignment information data derived above.

Preferably, the computer-implemented method further comprises the stepof:

-   -   being responsive to the aligned orthopaedic implant for updating        a library alignment information database with the alignment        information data.

Advantageously, the library alignment information database can beupdated with the alignment information data associated with the joint ofthe patient once the orthopaedic implant has been aligned to fit thepatient's joint according to the specific alignment information data.

According to another aspect of the present invention, there is provideda computing device for aligning an orthopaedic implant for a joint of apatient, the computing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, alignment information data            for a patient according to the computer-implemented method            as defined in any one of the preceding paragraphs; and        -   send, via the data interface, the alignment information data            to an alignment system for aligning the orthopaedic implant            relative to the joint of the patient.

Preferably, the alignment system is selected from a group of alignmentsystems comprising: a robotic alignment system, a haptic feedbackalignment system; and a computer-assisted alignment system.

Preferably, the computing device further comprises a database forstoring digital data including alignment information data, the databasebeing coupled to the processor, wherein the processor is furthercontrolled by the computer program code to:

-   -   update the database with the alignment information data        according to the aligned orthopaedic implant.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, alignment information data for        a patient according to the computer-implemented method as        defined in any one of the preceding paragraphs; and    -   sending, via the data interface, the alignment information data        to an alignment system for aligning the orthopaedic implant        relative to the joint of the patient.

Preferably, the alignment system is selected from a group of alignmentsystems comprising: a robotic alignment system, a haptic feedbackalignment system, and a computer-assisted alignment system.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   updating a database with the alignment information data        according to the aligned orthopaedic implant.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing device as defined in any one of the preceding paragraphs,wherein the interface is adapted for sending and receiving digital dataas referred to in any one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computer-implemented method for modelling the alignment of anorthopaedic implant for a joint of a patient, the computer-implementedmethod comprising the steps of:

-   -   being responsive to patient specific information data for        deriving patient data, the patient specific information data        being indicative of one or more dynamic characteristics; and    -   being responsive to the patient data for providing 3D model data        of the joint, such that the 3D model data shows the orthopaedic        implant in an alignment configuration based on the patient        specific information data.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information data.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the virtual prediction based on the jointkinematics data, joint loading data, and joint articulation behaviourdata.

Preferably, the virtual prediction comprises a computer modelprediction.

Advantageously, the virtual prediction of the joint kinematics data,joint loading data, and joint articulation behaviour data is provided asa computer model prediction to predict the alignment configuration ofthe orthopaedic implant for fitting the orthopaedic implant to thepatient's joint.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration oneor more static characteristics of the patient's joint.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration oneor more load bearing axes of a biomechanical reference frame of thepatient's joint.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration theprimary load bearing axis of the patient's joint.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration 2Dimaging data of the patient's joint.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration 3Dimaging data of the patient's joint.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration 4Dimaging data of the patient's joint.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration both2D and 3D imaging data of the patient's joint.

Preferably, the patient specific information data comprises data beingindicative of one or more physical characteristics of the patient.

Advantageously, the alignment configuration of the orthopaedic implantcan be accurately modelled for fitting the orthopaedic implant to thepatient's joint by virtue of the patient specific information dataassociated with the patient's joint which takes into consideration oneor more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer-implemented method further comprises the stepsof:

-   -   determining a set of possible alignment configurations according        to the patient data and patient acquired data, the patient        acquired data being indicative of one or more desired        post-implant activities, the patient acquired data comprising        post-implant activities preference data; and    -   selecting an alignment configuration from the set of possible        alignment configurations according to the post-implant        activities preference data.

Advantageously, the alignment configuration of the orthopaedic implantcan be selected for fitting the orthopaedic implant to the patient'sjoint by virtue of the patient specific information data associated withthe patient's joint which takes into consideration the patient'spreference for performing one or more desired post-implant activities.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Advantageously, the alignment configuration of the orthopaedic implantcan be selected for fitting the orthopaedic implant to the patient'sjoint by virtue of the patient specific information associated with thepatient's joint which takes into consideration comparative patientpreference for performing the one or more desired post-implantactivities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   accessing a database of library alignment configuration data,        wherein the alignment configuration is further selected        according to the library alignment configuration data.

Advantageously, the alignment configuration of the orthopaedic implantcan be selected for fitting the orthopaedic implant to the patient'sjoint by virtue of the patient specific information data associated withthe patient's joint which takes into consideration library alignmentconfigurations suitable for performing the one or more desiredpost-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Advantageously, the alignment configuration of the orthopaedic implantcan be selected for fitting the orthopaedic implant to the patient'sjoint by virtue of the patient specific information data associated withthe patient's joint which takes into consideration library alignmentconfigurations that relate to a group of available orthopaedic implantshaving been previously selected by other patients for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

Advantageously, the alignment configuration of the orthopaedic implantcan be selected for fitting the orthopaedic implant to the patient'sjoint by virtue of the patient specific information data associated withthe patient's joint which takes into consideration library alignmentconfigurations that relate to a group of patients having previously beenfitted with an orthopaedic implant suitable for performing at least oneof the one or more desired post-implant activities.

According to another aspect of the present invention, there is provideda computing device for modelling the alignment of an orthopaedic implantfor a joint of a patient, the computing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient specific            information data for deriving patient data, the patient            specific information data being indicative of one or more            dynamic characteristics;        -   calculate patient data according to the patient specific            information data; and        -   calculate 3D model data of the joint according to the            patient data, such that the 3D model data shows the            orthopaedic implant in an alignment configuration.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises data beingindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the processor is further controlled by the computer programcode to:

-   -   receive, via the data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculate a set of possible alignment configurations according        to the patient data and the patient acquired data; and    -   select an alignment configuration from the set of possible        alignment configurations according to the post-implant        activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computing device further comprises a database forstoring digital data including library alignment configuration data, thedatabase being coupled to the processor, wherein the processor isfurther controlled by the computer program code to:

-   -   load, from the database, the library alignment configuration        data, wherein the alignment configuration is further selected        according to the library alignment configuration data.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient specific information        data for deriving patient data, the patient specific information        being indicative of one or more dynamic characteristics;    -   calculating patient data according to the patient specific        information data; and    -   calculating 3D model data of a joint according to the patient        data, such that the 3D model data shows an orthopaedic implant        in an alignment configuration.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   receiving, via the data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculating a set of possible alignment configurations according        to the patient data and the patient acquired data; and    -   selecting an alignment configuration from the set of possible        alignment configurations according to the post-implant        activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computer readable storage medium further comprisesinstruction for:

-   -   loading from a database, library alignment configuration data,        wherein the alignment configuration is further selected        according to the library alignment configuration data.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing device as defined in any one of the preceding paragraphs,wherein the interface is adapted for sending and receiving digital dataas referred to in any one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computer-implemented method for selecting an orthopaedic implant for ajoint of a patient from a group of orthopaedic implants, thecomputer-implemented method comprising the steps of:

-   -   being responsive to patient specific information data for        deriving patient data, the patient specific information data        being indicative of one or more dynamic characteristics;    -   being responsive to the patient data for providing actual 3D        model data;    -   being responsive to the patient data for providing preferred 3D        model data of the joint; and    -   using the actual 3D model data and the preferred 3D model data        to select the orthopaedic implant from the group of orthopaedic        implants.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelbased on the one or more dynamic characteristics.

Preferably, the computer-implemented method further comprises the stepsof:

-   -   receiving patient acquired data, the patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data; and    -   being responsive to the post-implant activities preference data        for further optimizing the preferred 3D model data of the joint.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelwhich takes into consideration post-implant activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelwhich takes into consideration comparative patient preference forperforming the one or more desired post-implant activities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   accessing a database of library alignment configuration data,        wherein the preferred 3D model data of the joint is further        provided based on an optimization of the actual 3D model data        according to the library alignment configuration data.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelwhich takes into consideration library alignment configuration data.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelwhich takes into consideration library alignment configuration data thatrelates to a group of available orthopaedic implants having beenpreviously selected by other patients for performing at least one of theone or more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofcomparing the actual 3D model of the joint with a preferred 3D modelwhich takes into consideration library alignment configuration data thatrelates to a group of patients having previously been fitted with anorthopaedic implant suitable for performing at least one of the one ormore desired post-implant activities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   displaying a graphical user interface comprising at least the        preferred 3D model data of the joint.

Advantageously, the orthopaedic implant can be selected from the groupof orthopaedic implants for fitting to the patient's joint by virtue ofvisually comparing the actual 3D model of the joint with a preferred 3Dmodel displayed on the graphical user interface.

According to another aspect of the present invention, there is provideda computing device for selecting an orthopaedic implant for a joint of apatient from a group of orthopaedic implants, the computing devicecomprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient specific            information data for deriving patient data, the patient            specific information data being indicative of one or more            dynamic characteristics;        -   calculate actual 3D model data of the joint according to the            patient data;        -   calculate preferred 3D model data of the joint according to            the patient data; and        -   select the orthopaedic implant from the group of orthopaedic            implants according to the actual 3D model data and the            preferred 3D model data.

Preferably, the processor is further controlled by the computer programcode to:

-   -   receive, via the data interface, patient acquired data, the        patient acquired data being indicative of one or more desired        post-implant activities, the patient acquired data comprising        post-implant activities preference data; and    -   calculate the preferred 3D model data of the joint according to        the post-implant activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computing device further comprises a database forstoring digital data including library alignment configuration data, thedatabase being coupled to the processor, wherein the processor isfurther controlled by the computer program code to:

-   -   load from the database, the library alignment configuration        data, wherein the preferred 3D model of the joint is further        calculated based on an optimization of the actual 3D model data        according to the library alignment configuration data.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing oneor more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming one or more desired post-implant activities.

Preferably, the computing device further comprises a display devicecoupled to the processor, wherein the display device is controlled bythe computer program code to display a graphical user interfacecomprising at least the preferred 3D model data of the joint; the datainterface being controlled by the computer program code to receive atleast the preferred 3D model data of the joint.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient specific information        data for deriving patient data, the patient specific information        data being indicative of one or more dynamic characteristics;    -   calculating actual 3D model data of the joint according to the        patient data;    -   calculating preferred 3D model data of the joint according to        the patient data; and    -   selecting the orthopaedic implant from a group of implants        according to the actual 3D model data and the preferred 3D model        data.

Preferably, the computer readable storage medium further comprisesinstructions for

-   -   receiving, via the data interface, patient acquired data, the        patient acquired data being indicative of one or more desired        post-implant activities, the patient acquired data comprising        post-implant activities preference data; and    -   calculating the preferred 3D model data of the joint according        to the post-implant activities preference data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computer readable storage medium further comprisesinstruction for:

-   -   loading from a database, library alignment configuration data,        wherein the preferred 3D model data of the joint is further        calculated based on an optimization of the actual 3D model data        according to the library alignment configuration data.

Preferably, the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.

Preferably, the library alignment configuration data comprises datarelating to a group of patients fitted with an orthopaedic implant forperforming at least one of the one or more desired post-implantactivities.

Preferably, the computer readable storage medium further comprisesinstruction for:

-   -   displaying a graphical user interface comprising at least the        preferred 3D model data of the joint.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing as defined in any one of the preceding paragraphs, wherein theinterface is adapted for sending and receiving digital data as referredto in any one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computer-implemented method for developing manufacturing parametersfor manufacturing an orthopaedic implant for a joint of a patient havingan orthopaedic implant articulation surface, the computer-implementedmethod comprising the steps of:

-   -   being responsive to patient specific information data for        deriving patient data, the patient specific information data        being indicative of one or more dynamic characteristics;    -   being responsive to the patient data for calculating design data        for the orthopaedic implant; and    -   developing the manufacturing parameters for manufacturing the        orthopaedic implant according to the design data.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration patient specificinformation data indicative of one or more dynamic characteristics forcalculating design data for the orthopaedic implant.

Preferably, the patient specific information data comprises 2D imagingdata.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration 2D imaging data of thepatient's joint.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration 3D imaging data of thepatient's joint.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration 4D imaging data of thepatient's joint.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration both 2D and 3D imagingdata of the patient's joint.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration one or more desiredpost-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration a virtual predictionbased on the joint kinematics data, joint loading data, and jointarticulation behaviour data.

Preferably, the virtual prediction comprises a computer modelprediction.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration the virtual predictionof the joint kinematics data, joint loading data, and joint articulationbehaviour data provided as a computer model prediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration one or more staticcharacteristics of the patient's joint.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration one or more loadbearing axes of a biomechanical reference frame of the patient's joint.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration the primary loadbearing axis of the patient's joint.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration one or more physicalcharacteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer-implemented method further comprises the stepsof:

-   -   receiving patient acquired data, the patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   being responsive to the post-implant activities preference data        for calculating post-implant design data for the orthopaedic        implant; and    -   developing the manufacturing parameters for manufacturing the        orthopaedic implant further according to the post-implant design        data.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration the patient'spreference for performing one or more desired post-implant activities.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration comparative patientpreference for performing the one or more desired post-implantactivities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   accessing a database of library design data, wherein the        manufacturing parameters for manufacturing the orthopaedic        implant are further developed according to the library design        data.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration library design datasuitable for performing the one or more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration library design datathat relates to a group of available orthopaedic implants having beenpreviously selected by other patients for performing at least one of theone or more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing anorthopaedic implant having a desired articulation surface can bedeveloped by virtue of taking into consideration library design datathat relates to a group of patients having previously been fitted withan orthopaedic implant suitable for performing at least one of the oneor more desired post-implant activities.

According to another aspect of the present invention, there is provideda method for manufacturing an orthopaedic implant for a joint of apatient having an orthopaedic implant articulation surface, the methodcomprising the steps of:

-   -   developing manufacturing parameters using the        computer-implemented method as defined in any one of the        preceding paragraphs; and    -   manufacturing the orthopaedic implant according to the        manufacturing parameters.

Advantageously, an orthopaedic implant having a desired articulationsurface can be manufactured by virtue of taking into consideration themanufacturing parameters developed above.

Preferably, the orthopaedic implant is manufactured using amanufacturing process, comprising one or both of: an additivemanufacturing process, and a subtractive manufacturing process.

Advantageously, the orthopaedic implant having a desired articulationsurface can be manufactured according to either an additive orsubtractive manufacturing process.

Preferably, the additive manufacturing process comprises one or more of:stereolithography (SLA), selective laser sintering (SLS), direct metallaser sintering (DMLS), electron beam melting (EBM), and 3D printing(3DP).

Preferably, the subtractive manufacturing process comprises one or moreof: biomachining, abrasive flow machining, abrasive jet machining,milling, laser cutting, and water jet cutting.

According to another aspect of the present invention, there is providedan orthopaedic implant for a joint of a patient having an orthopaedicimplant articulation surface manufactured using the method as defined inany one of the preceding paragraphs.

According to another aspect of the present invention, there is provideda computing device for developing manufacturing parameters formanufacturing an orthopaedic implant for a joint of a patient having anorthopaedic implant articulation surface, the computing devicecomprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient specific            information data for deriving patient data, the patient            specific information being indicative of one or more dynamic            characteristics;        -   calculate patient data according to the patient specific            information data;        -   calculate design data for the orthopaedic implant according            to the patient data; and        -   calculate the manufacturing parameters for manufacturing the            orthopaedic implant according to the design data.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprises a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the processor is further controlled by the computer programcode to:

-   -   receive, via the data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculate post-implant design data for the orthopaedic implant        according to the post-implant activities preference data; and    -   calculate the manufacturing parameters for manufacturing the        orthopaedic implant further according to the post-implant design        data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computing device further comprises a database forstoring digital data including library design data, the database beingcoupled to the processor, wherein the processor is further controlled bythe computer program code to:

-   -   load from the database, the library design data, wherein the        manufacturing parameters for manufacturing the orthopaedic        implant are further calculated according to the library design        data.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient specific information        data for deriving patient data, the patient specific information        being indicative of one or more dynamic characteristics;        -   calculating patient data according to the patient specific            information data;        -   calculating design data for an orthopaedic implant according            to the patient data; and        -   calculating manufacturing parameters for manufacturing the            orthopaedic implant according to the design data.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprises a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   receiving, via the data interface, patient acquired data being        indicative of one or more desired post-implant activities, the        patient acquired data comprising post-implant activities        preference data;    -   calculating post-implant design data according to the        post-implant activities preference data; and    -   calculating manufacturing parameters for manufacturing the        orthopaedic implant according to the post-implant design data.

Preferably, the post-implant activities preference data is a preferenceratio being indicative of comparative patient preference for the one ormore desired post-implant activities.

Preferably, the computer readable storage medium further comprisesinstruction for:

-   -   loading from a database, library design data, wherein the        manufacturing parameters for manufacturing the orthopaedic        implant are further calculated according to the library design        data.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

According to another aspect of the present invention, there is provideda computer-implemented method for developing manufacturing parametersfor manufacturing a custom articulation for attachment to an orthopaedicimplant, the computer-implemented method comprising the steps of:

-   -   receiving design data according to the computer-implemented        method as defined in any one of the preceding paragraphs; and    -   developing the manufacturing parameters for manufacturing the        custom articulation according to the design data.

Advantageously, manufacturing parameters for manufacturing a customarticulation for attachment to an orthopaedic implant can be developedby virtue of taking into consideration the design data calculated fordeveloping the manufacturing parameters for the orthopaedic implant.

Preferably, the computer-implemented method further comprises the stepsof:

-   -   receiving post-implant design data according to the        computer-implemented method as defined in any one of the        preceding paragraphs; and    -   developing the manufacturing parameters for manufacturing the        custom implant further according to the post-implant design        data.

Advantageously, manufacturing parameters for manufacturing a customarticulation for attachment to an orthopaedic implant can be furtherdeveloped by virtue of taking into consideration the post-implant designdata corresponding to the patient's preference for performing one ormore desired post-implant activities.

Preferably, the computer-implemented method further comprises the stepof:

-   -   accessing a database of library design data, wherein the        manufacturing parameters for manufacturing the custom implant        are further developed according to the library design data.

Advantageously, manufacturing parameters for manufacturing a customarticulation for attachment to an orthopaedic implant can be developedfurther by virtue of taking into consideration the library design datasuitable for performing the one or more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing a customarticulation for attachment to an orthopaedic implant can be developedfurther by virtue of taking into consideration the library design datathat relates to a group of available orthopaedic implants having beenpreviously selected by other patients for performing at least one of theone or more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing a customarticulation for attachment to an orthopaedic implant can be developedfurther by virtue of taking into consideration the library design datathat relates to a group of patients having previously been fitted withan orthopaedic implant suitable for performing at least one of the oneor more desired post-implant activities.

According to another aspect of the present invention, there is provideda method for manufacturing a custom articulation for attachment to anorthopaedic implant, the method comprising the steps of:

-   -   developing manufacturing parameters using the        computer-implemented method as defined in any one of the        preceding paragraphs; and    -   manufacturing the custom articulation according to the        manufacturing parameters.

Advantageously, a custom articulation can be manufactured by virtue oftaking into consideration the manufacturing parameters developed above.

Preferably, the custom articulation is manufactured using amanufacturing process, comprising one or both of: an additivemanufacturing process, and a subtractive manufacturing process.

Advantageously, a custom articulation can be manufactured according toeither an additive or subtractive manufacturing process.

Preferably, the additive manufacturing process comprises one or more of:stereolithography (SLA), selective laser sintering (SLS), direct metallaser sintering (DMLS), electron beam melting (EBM), and 3D printing(3DP).

Preferably, the subtractive manufacturing process comprises one or moreof: biomachining, abrasive flow machining, abrasive jet machining,milling, laser cutting, and water jet cutting.

According to another aspect of the present invention, there is provideda custom articulation for attachment to an orthopaedic implantmanufactured using the method as defined in any one of the precedingparagraphs.

According to another aspect of the present invention, there is provideda computing device for developing manufacturing parameters formanufacturing a custom articulation for attachment to an orthopaedicimplant, the computing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, design data according to            the computer-implemented method as defined in any one of the            preceding paragraphs; and        -   calculate the manufacturing parameters for manufacturing the            custom articulation according to the design data.

Preferably, the processor is further controlled by the computer programcode to:

-   -   receive, via the data interface, post-implant design data        according to the computer-implemented method as defined in any        one of the preceding paragraphs; and    -   calculate the manufacturing parameters for manufacturing the        custom articulation further according to the post-implant design        data.

Preferably, the computing device further comprises a database forstoring digital data including library design data, the database beingcoupled to the processor, wherein the processor is further controlled bythe computer program code to:

-   -   load from the database, the library design data, wherein the        manufacturing parameters for manufacturing the custom        articulation are further calculated according to the library        design data.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, design data as defined        according to the computer-implemented method as defined in any        one of the preceding paragraphs; and    -   calculating manufacturing parameters for manufacturing a custom        articulation according to the design data.

Preferably, the computer readable storage medium further comprisesinstructions for:

-   -   receiving, via the data interface, post-implant design data        according to the computer-implemented method as defined in any        one of the preceding paragraphs; and    -   calculating the manufacturing parameters for manufacturing the        custom articulation according to the post-implant design data.

Preferably, the computer readable storage medium further comprisesinstruction for:

-   -   loading from a database, library design data, wherein the        manufacturing parameters for manufacturing the custom        articulation are further calculated according to the library        design data.

Preferably, the library design data comprises data relating to a groupof available orthopaedic implants for performing at least one of the oneor more desired post-implant activities.

Preferably, the library design data comprises data relating to a groupof patients fitted with an orthopaedic implant for performing at leastone of the one or more desired post-implant activities.

According to another aspect of the present invention, there is provideda computer-implemented method for developing manufacturing parametersfor manufacturing a patient specific jig for aligning an orthopaedicimplant to a joint of a patient, the computer-implemented methodcomprising the steps of:

-   -   being responsive to patient specific information data for        deriving patient data, the patient specific information data        being indicative of one or more dynamic characteristics;        -   being responsive to the patient data for calculating jig            design data for the patient specific jig; and        -   developing the manufacturing parameters for manufacturing            the patient specific jig according to the jig design data.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of taking into considerationpatient specific information data for calculating jig design data toenable the patient specific jig to be fitted to the joint of thepatient.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of taking into consideration oneor more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of taking into consideration avirtual prediction based on the joint kinematics data, joint loadingdata, and joint articulation behaviour data.

Preferably, the virtual prediction comprises a computer modelprediction.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of taking into consideration thevirtual prediction of the joint kinematics data, joint loading data, andjoint articulation behaviour data provided as a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration one or more staticcharacteristics of the patient's joint.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration one or more load bearingaxes of a biomechanical reference frame of the patient's joint.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration the primary load bearingaxis of the patient's joint.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration 2D imaging data of thepatient's joint.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration 3D imaging data of thepatient's joint.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration 4D imaging data of thepatient's joint.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration both 2D and 3D imagingdata of the patient's joint.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Advantageously, manufacturing parameters for manufacturing a patientspecific jig can be developed by virtue of deriving patient specificinformation data that takes into consideration one or more physicalcharacteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

According to another aspect of the present invention, there is provideda method for manufacturing a patient specific jig for aligning anorthopaedic implant to a joint of a patient, the method comprising thesteps of:

-   -   developing manufacturing parameters using the        computer-implemented method as defined in any one of the        preceding paragraphs; and    -   manufacturing the patient specific jig according to the        manufacturing parameters.

Preferably, the patient specific jig is manufactured using amanufacturing process, comprising one or both of: an additivemanufacturing process, and a subtractive manufacturing process.

Preferably, the additive manufacturing process comprises one or more of:

stereolithography (SLA), selective laser sintering (SLS), direct metallaser sintering (DMLS), electron beam melting (EBM), and 3D printing(3DP).

Preferably, the subtractive manufacturing process comprises one or moreof: biomachining, abrasive flow machining, abrasive jet machining,milling, laser cutting, and water jet cutting.

According to another aspect of the present invention, there is provideda patient specific jig for aligning an orthopaedic implant to a joint ofa patient manufactured using the method as defined in any one of thepreceding paragraphs.

According to another aspect of the present invention, there is provideda computing device for developing manufacturing parameters formanufacturing a patient specific jig for aligning an orthopaedic implantto a joint of a patient, the computing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient specific            information data for deriving patient data, the patient            specific information data being indicative of one or more            dynamic characteristics;        -   calculate patient data according to the patient specific            information data;        -   calculate jig design data for the patient specific jig            according to the patient data; and        -   calculate the manufacturing parameters for manufacturing the            patient specific jig according to the jig design data.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient specific information        data for deriving patient data, the patient specific information        data being indicative of one or more dynamic characteristics;    -   calculating patient data according to the patient specific        information data;    -   calculating jig design data for a patient specific jig according        to the patient data; and    -   calculating manufacturing parameters for manufacturing the        patient specific jig according to the jig design data.

Preferably, the patient specific information data comprises patientacquired data indicative of one or more desired post-implant activities.

Preferably, the one or more dynamic characteristics comprise a virtualprediction based on one or more of: joint kinematics data; joint loadingdata; and joint articulation behaviour data during desired post-implantactivities.

Preferably, the virtual prediction comprises a computer modelprediction.

Preferably, the patient specific information data is indicative of oneor more static characteristics.

Preferably, the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.

Preferably, the one or more load bearing axes of the biomechanicalreference frame comprises a primary load bearing axis.

Preferably, the one or more static characteristics comprise one or moreload bearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.

Preferably, the patient specific information data comprises 2D imagingdata.

Preferably, the 2D imaging data comprises one or more of: X-Ray data andvisual fluoroscopy data.

Preferably, the patient specific information data comprises 3D imagingdata.

Preferably, the 3D imaging data comprises one or more of: MagneticResonance Imaging (MRI) data, Computed Tomography (CT) data, ultrasounddata, radiological data, and motion capture data.

Preferably, the patient specific information data comprises 4D imagingdata.

Preferably, the 4D imaging data comprises motion capture data.

Preferably, the patient specific information data comprises 2D and 3Dimaging data.

Preferably, the patient specific information data comprises dataindicative of one or more physical characteristics of the patient.

Preferably, the one or more physical characteristics comprises one ormore of: age data, gender data, height data, weight data, activity leveldata, BMI data, body condition data, and body shape data.

According to another aspect of the present invention, there is provideda computer-implemented method for calculating implant design data for agroup of orthopaedic implants, the computer-implemented methodcomprising the steps of:

-   -   receiving patient library data;    -   receiving implant range data; and    -   calculating the implant design data for the group of orthopaedic        implants according to the patient library data and the implant        range data.

Advantageously, implant design data can be calculated for a group oforthopaedic implants by virtue of taking into consideration patientlibrary data and implant range data.

Preferably, the patient library data comprises alignment informationdata of multiple orthopaedic implants of multiple patients provided bythe computer-implemented method as defined in any one of the precedingparagraphs.

Advantageously, implant design data can be calculated for a group oforthopaedic implants by virtue of taking into consideration alignmentinformation data of multiple orthopaedic implants of multiple patients.

Preferably, the implant range data is indicative of one or more subsetsof the patient library data selected according to a user input request.

Advantageously, implant design data can be calculated for a group oforthopaedic implants by virtue of selecting one or more subsets of thepatient library data.

Preferably, at least one of the one or more subsets comprises patientsatisfaction data relating to a number of satisfied patients selectedfrom a group of patients fitted with an orthopaedic implant forperforming one or more post-implant activities.

Preferably, at least one of the one or more subsets comprises implantactivity data relating to a number of orthopaedic implants selected froma group of orthopaedic implants for performing one or more post-implantactivities.

Preferably, at least one of the one or more subsets comprises implantsize data relating to a number of orthopaedic implants of a particularsize range selected from a group of orthopaedic implants for performingone or more post-implant activities.

Preferably, revised patient library data is calculated on the basis offiltering the patient library data according to the implant range data.

Advantageously, implant design data can be calculated for a group oforthopaedic implants by virtue of taking into consideration patientlibrary data that has been filtered according to the implant range data.

Preferably, the implant design data is calculated according to astatistical analysis of the revised patient library data.

Advantageously, implant design data can be calculated for a group oforthopaedic implants by virtue of a statistical analysis of the patientlibrary data revised according to the implant range data.

Preferably, the statistical analysis is selected from a group ofstatistical analyses comprising: regression analysis and least squaresanalysis.

According to another aspect of the present invention, there is provideda computing device for calculating implant design data for a group oforthopaedic implants, the computing device comprising:

-   -   a processor for processing digital data;    -   a memory device for storing digital data including computer        program code and being coupled to the processor via a bus; and    -   a data interface for sending and receiving digital data and        being coupled to the processor via the bus, wherein the        processor is controlled by the computer program code to:        -   receive, via the data interface, patient library data;        -   receive, via the data interface, implant range data; and        -   calculate the implant design data for the group of            orthopaedic implants according to the patient library data            and the implant range data.

Preferably, the patient library data comprises alignment informationdata of multiple orthopaedic implants of multiple patients provided bythe computer-implemented method as defined in any one of the precedingparagraphs.

Preferably, the implant range data is indicative of one or more subsetsof the patient library data selected according to a user input request.

Preferably, at least one of the one or more subsets comprises patientsatisfaction data relating to a number of satisfied patients selectedfrom a group of patients fitted with an orthopaedic implant forperforming one or more post-implant activities.

Preferably, at least one of the one or more subsets comprises implantactivity data relating to a number of orthopaedic implants selected froma group of orthopaedic implants for performing one or more post-implantactivities.

Preferably, at least one of the one or more subsets comprises implantsize data relating to a number of orthopaedic implants of a particularsize range selected from a group of orthopaedic implants for performingone or more post-implant activities.

Preferably, revised patient library data is calculated on the basis offiltering the patient library data according to the implant range data.

Preferably, the implant design data is calculated according to astatistical analysis of the revised patient library data.

Preferably, the statistical analysis is selected from a group ofstatistical analyses comprising: regression analysis and least squaresanalysis.

According to another aspect of the present invention, there is provideda computer readable storage medium comprising computer program codeinstructions, being executable by a computer, for:

-   -   receiving, via a data interface, patient library data;    -   receiving, via the data interface, implant range data; and    -   calculating implant design data for a group of orthopaedic        implants according to the patient library data and the implant        range data.

Preferably, the patient library data comprises alignment informationdata of multiple orthopaedic implants of multiple patients provided bythe computer-implemented method as defined in any one of the precedingparagraphs.

Preferably, the implant range data is indicative of one or more subsetsof the patient library data selected according to a user input request.

Preferably, at least one of the one or more subsets comprises patientsatisfaction data relating to a number of satisfied patients selectedfrom a group of patients fitted with an orthopaedic implant forperforming one or more post-implant activities.

Preferably, at least one of the one or more subsets comprises implantactivity data relating to a number of orthopaedic implants selected froma group of orthopaedic implants for performing one or more post-implantactivities.

Preferably, at least one of the one or more subsets comprises implantsize data relating to a number of orthopaedic implants of a particularsize range selected from a group of orthopaedic implants for performingone or more post-implant activities.

Preferably, revised patient library data is calculated on the basis offiltering the patient library data according to the implant range data

Preferably, the implant design data is calculated according to astatistical analysis of the revised patient library data.

Preferably, the statistical analysis is selected from a group ofstatistical analyses comprising: regression analysis and least squaresanalysis.

According to another aspect of the present invention, there is provideda client computing device comprising an interface for sending andreceiving digital data and being coupled, across a data link, to acomputing device as defined in any one of the preceding paragraphs,wherein the interface is adapted for sending and receiving digital dataas referred to in any one of the preceding paragraphs.

Other aspects of the invention are also disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

Notwithstanding any other forms which may fall within the scope of thepresent invention, preferred embodiments of the invention will now bedescribed, by way of example only, with reference to the accompanyingdrawings in which:

FIG. 1 shows a computing device on which the various embodimentsdescribed herein may be implemented in accordance with a preferredembodiment of the present invention;

FIG. 2 shows a network of computing devices on which the variousembodiments described herein may be implemented in accordance with apreferred embodiment of the present invention;

FIG. 3 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 4 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 5 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 6 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 7 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 8 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 9 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 10 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 11 shows a computer-implemented method in accordance with anembodiment of the present invention;

FIG. 12 is a graphic representation of a response curve demonstrating afunctional kinematic response for a knee joint;

FIG. 13 is a schematic representation of a file stored in a database ofthe computing device of FIG. 1;

FIGS. 14A, 14B and 14C show graphical representations of predictedcomputer simulation results for the change in varus angle (in degrees)of a knee joint of a patient based on alignment information datacalculated using a computer-implemented method in accordance with anembodiment of the present invention, shown for a generally standingposition, FIG. 14A, a generally kneeling position, FIG. 14C, and anintermediate position, FIG. 14B;

FIGS. 15A, 15B and 15C show graphical representations of predictedcomputer simulation results for the change in quadricept force (innewtons) of a knee joint of a patient based on alignment informationdata calculated using a computer-implemented method in accordance withan embodiment of the present invention, shown for a generally standingposition, FIG. 15A, a generally kneeling position, FIG. 15C, and anintermediate position, FIG. 15B;

FIGS. 16A, 16B and 16C show graphical representations of predictedcomputer simulation results for the change in internal-external rotation(in degrees) of a knee joint of a patient based on alignment informationdata calculated using a computer-implemented method in accordance withan embodiment of the present invention, shown for a generally standingposition, FIG. 16A, a generally kneeling position, FIG. 16C, and anintermediate position, FIG. 16B;

FIGS. 17A, 17B and 17C show graphical representations of predictedcomputer simulation results for the change in patella lateral shearforce (in newtons) of a knee joint of a patient based on alignmentinformation data calculated using a computer-implemented method inaccordance with an embodiment of the present invention, shown for agenerally standing position, FIG. 17A, a generally kneeling position,FIG. 17C, and an intermediate position, FIG. 17B;

FIGS. 18A, 18B and 18C show graphical representations of predictedcomputer simulation results for the change in internal-external rotation(in degrees) of a knee joint of a patient at three differentvarus/valgus angles based on alignment information data calculated usinga computer-implemented method in accordance with an embodiment of thepresent invention, shown for a generally standing position, FIG. 18A, agenerally crouching or squatting position, FIG. 18C, and an intermediateposition, FIG. 18B;

FIGS. 19A and 19B shows graphical representations of predicted computersimulation results for the change in various parameters of a knee jointof a patient based on alignment information data calculated using acomputer-implemented method in accordance with an embodiment of thepresent invention, shown for a generally standing position, FIG. 19A,and a generally kneeling position, FIG. 19B;

FIGS. 20A and 20B show graphical representations of library alignmentinformation data obtained for a group of eight patients, each fittedwith an orthopaedic implant, for use in selecting alignment informationdata for the alignment of an orthopaedic implant for a joint of apatient in accordance with an embodiment of the present invention, shownfor the change in internal-external rotation of the left and right kneejoints, FIG. 20A, and the change in patella shear force, FIG. 20B, whenmoving from a generally standing to a generally crouching or squattingposition;

FIGS. 21A, 21B and 21C show graphical representations of predictedcomputer simulation results for the change in hip load (in newtons) ofthe left and right hip joints of a patient based on alignmentinformation data calculated using a computer-implemented method inaccordance with an embodiment of the present invention, shown for agenerally standing position, FIG. 21A, a generally crouching position,FIG. 21B, and then returning to a generally standing position, FIG. 21C;

FIGS. 22A, 22B and 22C show graphical representations of predictedcomputer simulation results for the placement (in degrees) of anacetabular cup of a hip joint of a patient based on alignmentinformation data calculated using a computer-implemented method inaccordance with an embodiment of the present invention, shown for agenerally standing position, FIG. 22A, and a generally sitting position,FIG. 22B, with FIG. 22C showing a corresponding 2D plot that isrepresentative of the interior articulation surface of the acetabularcup;

FIGS. 23A, 23B and 23C show graphical representations of predictedcomputer simulation results for the placement (in degrees) of anacetabular cup of a hip joint of a patient based on alignmentinformation data calculated using a computer-implemented method inaccordance with an embodiment of the present invention, shown for agenerally standing position, FIG. 23A, and a generally sitting position,FIG. 23B, with FIG. 23C showing a corresponding 2D plot that isrepresentative of the interior articulation surface of the acetabularcup;

FIG. 24A shows a plot for calculating implant design data for a group oforthopaedic implants in accordance with an embodiment of the presentinvention, FIG. 24B showing a legend for the plot of FIG. 24A; and

FIG. 25 shows a plot for calculating implant design data for a group oforthopaedic implants in accordance with an embodiment of the presentinvention;

DESCRIPTION OF EMBODIMENTS

It should be noted in the following description that like or the samereference numerals in different embodiments denote the same or similarfeatures.

FIG. 1 shows a computing device 100 on which the various embodimentsdescribed herein may be implemented. The computer program codeinstructions may be divided into one or more computer program codeinstruction libraries, such as dynamic link libraries (DLL), whereineach of the libraries performs a one or more steps of the method.Additionally, a subset of the one or more of the libraries may performgraphical user interface tasks relating to the steps of the method.

The computing device 100 comprises semiconductor memory 110 comprisingvolatile memory such as random access memory (RAM) or read only memory(ROM). The memory 100 may comprise either RAM or ROM or a combination ofRAM and ROM.

The computing device 100 comprises a computer program code storagemedium reader 130 for reading the computer program code instructionsfrom computer program code storage media 120. The storage media 120 maybe optical media such as CD-ROM disks, magnetic media such as floppydisks and tape cassettes or flash media such as USB memory sticks.

The computing device 100 further comprises I/O interface 140 forcommunicating with one or more peripheral devices. The I/O interface 140may offer both serial and parallel interface connectivity. For example,the I/O interface 140 may comprise a Small Computer System Interface(SCSI), Universal Serial Bus (USB) or similar I/O interface forinterfacing with the storage medium reader 130. The I/O interface 140may also communicate with one or more human input devices (HID) 160 suchas keyboards, pointing devices, joysticks and the like. The I/Ointerface 140 may also comprise a computer to computer interface, suchas a Recommended Standard 232 (RS-232) interface, for interfacing thedevice 100 with one or more personal computer (PC) devices 190. The I/Ointerface 140 may also comprise an audio interface for communicate audiosignals to one or more audio devices 1050, such as a speaker or abuzzer.

The computing device 100 also comprises a network interface 170 forcommunicating with one or more computer networks 180. The network 180may be a wired network, such as a wired Ethernet™ network or a wirelessnetwork, such as a Bluetooth™ network or IEEE 802.11 network. Thenetwork 180 may be a local area network (LAN), such as a home or officecomputer network, or a wide area network (WAN), such as the Internet 230or private WAN.

The computing device 100 comprises an arithmetic logic unit or processor1000 for performing the computer program code instructions. Theprocessor 1000 may be a reduced instruction set computer (RISC) orcomplex instruction set computer (CISC) processor or the like. Thecomputing device 100 further comprises a storage device 1030, such as amagnetic disk hard drive or a solid state disk drive.

Computer program code instructions may be loaded into the storage device1030 from the storage media 120 using the storage medium reader 130 orfrom the network 180 using network interface 170. During the bootstrapphase, an operating system and one or more software applications areloaded from the storage device 1030 into the memory 110. During thefetch-decode-execute cycle, the processor 1000 fetches computer programcode instructions from memory 110, decodes the instructions into machinecode, executes the instructions and stores one or more intermediateresults in memory 100.

The computing device 100 also comprises a video interface 1010 forconveying video signals to a display device 1020, such as a liquidcrystal display (LCD), cathode-ray tube (CRT) or similar display device.

The computing device 100 also comprises a communication bus subsystem150 for interconnecting the various devices described above. The bussubsystem 150 may offer parallel connectivity such as Industry StandardArchitecture (ISA), conventional Peripheral Component Interconnect (PCI)and the like or serial connectivity such as PCI Express (PCIe), SerialAdvanced Technology Attachment (Serial ATA) and the like.

FIG. 2 shows a network 200 of computing devices 100 on which the variousembodiments described herein may be implemented. The network 200comprises a web server 210 for serving web pages to one or more clientcomputing devices 220 over the Internet 230.

The web server 210 is provided with a web server application 240 forreceiving requests, such as Hypertext Transfer Protocol (HTTP) and FileTransfer Protocol (FTP) requests, and serving hypertext web pages orfiles in response. The web server application 240 may be, for examplethe Apache™ or the Microsoft™ IIS HTTP server.

The web server 210 is also provided with a hypertext preprocessor 250for processing one or more web page templates 260 and data from one ormore databases 270 to generate hypertext web pages. The hypertextpreprocessor may, for example, be the PHP: Hypertext Preprocessor (PHP)or Microsoft Asp™ hypertext preprocessor. The web server 210 is alsoprovided with web page templates 260, such as one or more PHP or ASPfiles.

Upon receiving a request from the web server application 240, thehypertext preprocessor 250 is operable to retrieve a web page template,from the web page templates 260, execute any dynamic content therein,including updating or loading information from the one or more databases270, to compose a hypertext web page. The composed hypertext web pagemay comprise client side code, such as Javascript, for Document ObjectModel (DOM) manipulating, asynchronous HTTP requests and the like.

Client computing devices 220 are provided with a browser application280, such as the Mozilla Firefox™ or Microsoft Internet Explorer™browser applications. The browser application 280 requests hypertext webpages from the web server 210 and renders the hypertext web pages on adisplay device 1020.

The computing device 100 enables thin client communications with remoteusers. However, in other embodiments, remote users need to have specificsoftware installed on the relevant client computing devices 220 topermit communication with the computing device 100.

Providing Alignment Information Data

FIG. 3 shows a computer-implemented method 300 for providing alignmentinformation data for the alignment of an orthopaedic implant for a jointof a patient in accordance with an embodiment of the present invention.The computer-implemented method 300 is suited for implementation on oneor more computing devices 100 and in particular one or more computingdevices 100 communicating across a network 200, as substantially shownin FIG. 2.

Specifically, such a computing device 100 comprises a processor 1000 forprocessing digital data, a memory device 110 for storing digital dataincluding computer program code and being coupled to the processor 1000via a communications bus 150, a data interface (180, 140) for sendingand receiving digital data and being coupled to the processor 1000 viathe bus 150, and a storage device such as a database 1030 for storingdigital data including the alignment information data, and library data,and being coupled to the processor 1000 via the bus 150.

Library Data

The library data stored in the database 1030 includes—library alignmentinformation data, library alignment configuration data, and librarydesign data that are indicative of a set of available predeterminedsimulation models for the movement of a generalized and idealized jointduring a respective predetermined post-implant activity. Each simulationmodel is created by taking various measurements from a sample of testsubjects performing movements for the particular predetermined activity.These measurements are collated and processed to produce the idealsimulation model. In embodiments, the ideal simulation models are notonly differentiated by the post-implant activity, but also by otherfactors such as gender data, age data, height data, weight data,activity level data, BMI data, body condition data, and body shape data,medical history, occupation, and race, among others.

The library data also includes library alignment configuration datarelating to a group of available orthopaedic implants for performingpost-implant activities and library alignment configuration datarelating to a group of patients fitted with an orthopaedic implant forperforming post-implant activities. The orthopaedic implants may becommercially available orthopaedic implants, or orthopaedic implantsthat have been customised specifically for previous patients.

The library data also includes library design data for the group ofavailable orthopaedic implants from which the structural parameters ofthe orthopaedic implants can be derived. The library design data may beprovided in the form of, for example, a CAD file.

The library data also includes data relating to the durability and wearof orthopaedic implants that have been prior fitted to patients. Suchdata can be obtained by using, for example, 2D and 3D imaging techniquessuch as Magnetic Resonance Imaging (MRI) data, Computed Tomography (CT)data, ultrasound data, and radiological data, and recording such data atvarious time intervals. The obtained durability and wear score dataassociated with the orthopaedic implants can then be used to assist anoperator, such as a surgeon, in predicting how well an orthopaedicimplant having the same structural parameters that a now wornorthopaedic implant had prior to being implanted, will perform inanother patient.

The library data may also include subjective metrics relating to apatient's own view of the biomechanical performance of their jointpost-implant surgery, and objective metrics directed to the patient bythe operator, such as a surgeon, to understand how the joint and theorthopaedic implant are actually performing post-implant surgery, inquantifiable terms.

The computer-implemented method 300 starts at step 310 where theprocessor 1000 is controlled by the computer program code to receive,via the data interface (180, 140), patient specific information dataspecific to the patient to be fitted with an orthopaedic implant, andindicative of one or more dynamic characteristics. The patient specificinformation data is buffered and then compiled by the computing device100 as patient file 7 in an electronic form for storing in the database1030. The processor 1000 is further controlled by the computer programcode, at step 320, to calculate patient data according to the patientspecific information data contained within the patient file 7. In thisstep, the computing device 100 receives the patient file 7 from thedatabase 1030 via bus 150 and then derives at least a portion of thepatient data by virtue of segmenting and filtering out any unwanted datafrom the patient file 7. Such unwanted data may include a variety ofinformation that represents non-essential tissues in the joint, forexample muscle, fat and skin, amongst others. This allows the isolationand more streamlined analysis of only the relevant data. This filtrationof unwanted data can be partially automated but for the presentembodiment, manual inputs are generally required.

Patient Specific Information Data

The patient specific information data comprises 2D and 3D imaging dataof the bone geometry of the joint. The 2D imaging data comprises dataobtained using such techniques as X-Ray and visual fluoroscopy, whilethe 3D imaging data comprises data obtained using such techniques asMagnetic Resonance Imaging (MRI) data, Computed Tomography (CT) data,ultrasound data, and radiological data. The patient specific informationdata also comprises 4D imaging data obtained using such techniques asmotion capture. Such 4D imaging may entail placing markers (not shown)at various locations on the relevant bones associated with the joint andthen tracking the motion of the markers as the patient engages in adesired activity.

The patient specific information data also comprises data indicative ofone or more physical characteristics of the patient, such as: age data,gender data, height data, weight data, activity level data, BMI data,body condition data, race, and body shape data, among others. Otherpatient specific information data may comprise data indicative of thehistory of the patient and the history of other family members for thepurpose of identifying any heredity defects that have occurred, or mightoccur in the patient in the future.

Once the patient file 7 has been filtered, relevant anatomical landmarksin the joint are then manually identified and identificationinstructions are entered via the data interface (180, 140). Thecomputing device 100 is responsive to the identification instructions todefine at least another portion of the patient data from the highlightidentified landmarks. It has been found that each joint has specialanatomical features that need to be considered. Examples of suchlandmarks include bony protuberances called prominences, lines betweenlandmarks, and ligament and tendon insertions and attachments.

In embodiments, relevant anatomical landmarks in the joint areautomatically identified using such processes as functional referencing,algorithmic identification of anatomy, and algorithmic identification ofmoment arms. In other embodiments, semi-automatic identification ofrelevant anatomical landmarks is used such as forms of functionalimaging, including visual fluoroscopy and endoscopy.

As shown in FIG. 13, the patient file 7 comprises first and second data15 and 16. Data 15 includes information records indicative of one ormore dynamic characteristics and data 16 includes information recordsindicative of one or more static characteristics.

Dynamic Characteristics

The dynamic characteristics of the joint comprise data in the form of avirtual prediction, namely a computer model prediction based on jointkinematics data, joint loading data, and joint articulation behaviourdata in response to particular movements, patient specific loads, momentarms, contact stresses, external forces, and muscle forces, amongstothers, associated with the patient's desired post-implant activities.

Data 15 is based on an array of records, where each record correspondsto a selected one of the set of available predetermined ideal simulationmodels included within the library alignment information data, libraryalignment configuration data, and library design data stored in thedatabase 1030.

Each model in the set of models corresponds to a particular jointperforming a particular activity. For example, a record 21 included indata 15 corresponds to a model of the movements anticipated to beperformed by a generalized knee joint at those times when the associatedhuman body is partaking in a game of tennis. That is, this modelprovides the ideal knee joint configuration and range of articulation,amongst other quantifiable factors, for a person playing tennis based onthe specific movements a tennis player makes. A record 22 corresponds toa model of the movements of a generalized knee joint when the associatedhuman body is undertaking the action of climbing up and down a staircaseand includes a plurality of quantifications (of different quantum).

In other embodiments, data 15 is based upon a single record.

In one embodiment, data 15 is indicative of at least two simulationmodels. In further embodiments, data 15 is indicative of more or lessthan two simulation models.

Static Characteristics

Data 16 is indicative of the static characteristics of the joint andincludes one or more stationary measurements taken of the joint and/orof its alignment relative to other physiological components specific tothe patient. Available stationary measurements comprise: the mechanicalaxis alignment; a range of motion simulations based on implant shape andpatient anatomy; and others that would be appreciated by those skilledin the art given the benefit of the teaching herein. In the case of themechanical axis alignment data, such data corresponds to the particularmechanical load bearing axes of a biomechanical reference frameassociated with the joint. In the case where the joint corresponds to aknee or hip joint, then such biomechanical reference frames include theacetabular reference frame, the femoral reference frame, the tibialreference frame, and the spinal reference frame. Such mechanical loadbearing axes when combined result in a primary mechanical load bearingaxis, corresponding to the overall mechanical axis alignment of thejoint. It will be appreciated that the biomechanical reference framesare not limited to those related to the knee and hip as described above,but may also include reference frames associated with other joints ofthe body including the shoulder, and ankle, among others.

As shown in FIG. 13, data 16 includes an array of records correspondingto static properties or characteristics of the joint. More particularly,in this embodiment, data 16 contains a plurality of images of the joint.These images include a Magnetic Resonance Imaging (MRI) image, in theform of record 25, a Computed Tomography (CT) image, in the form ofrecord 26, and an X-ray image, in the form of record 27. Embedded andinherent within, and extractable from, these images are many stationaryor static measures for the joint.

Records 25, 26 and 27 are in DICOM (Digital Imaging and Communicationsin Medicine) format for allowing, as will be described below, theautomated extraction of a number of static characteristics of the joint.In other embodiments, records 25, 26 and 27 are an image that isdigitized for then allowing the required characteristics to beextracted. In other embodiments, records 25, 26 and 27 is other than aDICOM format which still allows automated extraction of a number ofstatic characteristics of the joint.

In other embodiments, data 16 is indicative of information other thanimages, while in further embodiments, different images are used insteadof or in addition to those explicitly mentioned above. Examples of otherimages include ultrasound images, laser scans, and scans from pointmatching, surface matching and/or surface recognition, amongst others.It is also appreciated that a person skilled would recognize with thebenefit of the teaching herein, that such images are able, in someinstances, to be used to derive one or more of the records included indata 15.

In summary, the filtered and identified information from the patientfile 7 defines the patient data, which is then stored in the database1030.

At step 330, the processor 1000 is further controlled by the computerprogram code to calculate the alignment information data for aligningthe orthopaedic implant for the joint according to the patient data. Inthis step, the patient data is retrieved from the database 1030 and adeterministic patient specific rigid body mechanics simulation isperformed on the patient data using a physics engine, that is, asimulation of the joint using multi-body simulation software.

The simulation is a multi-body simulation which could include the use offorward and/or inverse dynamics in order to produce knee or hip jointsimulations.

The alignment information data comprises an actual 3D model data of thejoint, as obtained from the various 2D and 3D imaging data stored indata 16. From data 15 and data 16, it is possible to generate datacorresponding to magnitudes and directions of force vectors, loads,shear stresses, and moments associated with the orthopaedic implantduring the simulation. The alignment information data thus takes intoconsideration both location information data and orientation informationdata for locating and orienting, respectively, the orthopaedic implantrelative to the joint.

At step 340, the processor 1000 is controlled by the computer programcode to receive, via the data interface (180, 140), patient acquireddata 58 indicative of one or more desired post-implant activities of thepatient. The one or more post-implant activities relate to the numberand type of activities that the patient would like to eventually fulfilafter an implant operation has been undertaken. In this embodiment, thepost-implant activities are categorized into day to day activities (suchas, for example, climbing up and down a stair case, getting in and outof a car, picking up their grandchildren), outdoor activities (forexample kneeling in the garden for the purposes of gardening, casualjogging) and sporting activities (such as, for example, playing tennis,golf, skiing, football, or any defined kinematic propositions). It willbe appreciated that in other embodiments, the post-implant activitiesare not limited to those described above, but may comprise any desiredactivity of the patient. Such patient acquired data 58 is obtained byvirtue of the patient communicating remotely with the computing device100 via a client computing device 220. The client computing device 220comprises an interface for sending and receiving digital data and iscoupled, across a data link, to the computing device 100. The patientprovides the patient acquired data 58 in the form of an electronicquestionnaire (not shown), which is submitted by the patient or ahealthcare professional via the client computing device 220 to thecomputing device 100. The patient acquired data 58 is stored as a recordin data 15 in the patient file 7 in the database 1030.

The patient acquired data 58 comprises post-implant activitiespreference data, which is a preference ratio being indicative ofcomparative patient preference for the one or more desired post-implantactivities. In this sense, the patient can order their preferredpost-implant activities in terms of specific personal preference. Forexample, where one patient wishes to be able to kneel in the garden soas to attend to gardening, and occasionally play tennis, the preferenceratio orders kneeling in the garden ahead of playing tennis. In the caseof a knee joint, the action of kneeling would require extensive flexionof the joint, but minimal varus/valgus and internal/external rotation ofthe joint. On the other hand, the action of playing tennis would requirea greater degree of varus/valgus and internal/external rotation of thejoint.

Other types of patient metrics that may appear in the questionnairecould include subjective metrics relating to the patient's own view ofthe biomechanical performance of the joint pre-implant surgery, andobjective metrics directed to the patient by the operator, such as asurgeon, to understand how the joint is actually performing pre-implantsurgery, in quantifiable terms. A surgeon can use such patient metricsto understand the current limitations of the patient's joint.

Essentially, the questionnaire provides a predetermined list ofpost-implant activities of which the patient would rate in order ofpersonal preference. The post-implant activities preference data thusforms a patient functional score that can then be used to defineboundary conditions in a multi-body simulation to assist an operator inidentifying the most appropriate orthopaedic implant to enable thepatient to achieve the desired post-implant activities.

In other embodiments, the questionnaire is a paper survey (not shown)that is filled out by the patient and then entered manually into thedatabase 1030 by, for example, an operator or a surgeon, via the datainterface (180, 140).

In other embodiments, the patient acquired data 58 is input into thequestionnaire remotely via a personal digital assistant (PDA) such as,for example, an iPhone and/or iPad application (not shown).

At step 350, once the patient acquired data 58 has been input by theuser, the processor 1000 is controlled by the computer program code tocalculate a set of possible alignment information data according to thepatient data and the patient acquired data 58. In this step, thesimulation of the joint is tested against the patient acquired data 58with respect to the post-implant activities. This is known as theimprovement approach. Essentially, this step examines the simulatedjoint in conjunction with the desired motion of the post-implantactivities to show where, amongst others, the maximum functionalkinematic response will occur on the patient's joint for that particularmovement. The set of possible alignment information data thus takes intoconsideration the alignment information data relating to the actualjoint of the patient in its current state and the alignment informationdata that would enable the patient to perform the desired post-implantactivities.

At step 360, the processor 1000 is controlled by the computer programcode to select alignment information data from the set of possiblealignment information data according to the post-implant activitiespreference data. In this step, once the one or more points of maximumfunctional kinematic response are identified, certain variables, forexample, the positioning and shape of the articulation surface of theorthopaedic implant are varied as desired to thereby produce asimulation file, which is stored in the database 1030 for future accessby the operator or by one or more remote users. The selected alignmentinformation data thus relates to alignment information data that wouldenable the patient to perform their desired post-implant activitiesaccording to their personal preference. So, for the example above, theselected alignment information data would allow a high degree of flexionof the knee joint to allow the patient to preferentially perform theaction of kneeling in the garden, but still have a reasonable degree ofvarus/valgus and internal/external rotation of the joint to afford thepatient with the ability to play the occasional game of tennis.

The simulation file is a DICOM (Digital Imaging and Communications inMedicine) file comprising 2D slices that can be viewed in 3D bycompiling the 2D slices using image processing software. In otherembodiments, other image file-types are used such as STL, JPEG, GIF, andTIF.

In other embodiments, operators can virtually implant an orthopaedicimplant into the joint of the patient in order to identify optimalalignment configurations and orientations of that orthopaedic implantthat will yield the best biomechanical performance for the desiredpost-implant activities.

At step 370, the processor 1000 is further controlled by the computerprogram code to load, from the database 1030, library alignmentinformation data corresponding to alignment information data relating toa group of available orthopaedic implants for performing at least one ofthe one or more desired post-implant activities or alignment informationdata relating to a group of patients fitted with an orthopaedic implantfor performing at least one of the one or more desired post-implantactivities. In this step, the alignment information data for aligningthe orthopaedic implant to the joint of the patient can be furtherimproved by virtue of comparing the selected alignment information datafor the simulated joint developed by the multi-body simulation with thelibrary alignment information data associated with commerciallyavailable orthopaedic implants or patients fitted with orthopaedicimplants that are known to be suitable for performing at least one ofthe one or more desired post-implant activities of the patient.

The data interface (180, 140) is responsive to a user input from theclient computing device 220 to enable a remote user, such as a surgeon,to access the simulation file from the database 1030 to generate, bufferand display, for example, a graphic representation of the joint derivedfrom the simulation file. The data interface (180, 140) is alsoaccessible by remote users by logging on to a web page (not shown) viathe Internet 230 using, for example, a pre-defined username and/orpassword.

It will be appreciated that all data stored in the database 1030 iscategorized with a security level and all remote users accessing thedata via a client computing device 220 will have an allocated securityaccess rights. Access to any specific data is regulated based upon notonly the security level of the data itself and the security accessrights of the remote user seeking access to the data, but also on therelationship between the patient from whom the data is derived and theuser. In this way, the operator assisting the patient is able toselectively input at least some of the patient specific informationdata, such as CT scans and MRI scans for the patient, as well aspersonal preferences for the post-implant activities. In otherembodiments, more or less access to information is provided to selectedpersons.

Selecting an Implant from Group of Implants

FIG. 4 shows a computer-implemented method 400 for selecting anorthopaedic implant for a joint of a patient from a group of availableorthopaedic implants in accordance with another embodiment of thepresent invention. The computer-implemented method 400 starts at step410 where the processor 1000 is controlled by the computer program codeto receive from the database 1030, via the data interface (180, 140),the alignment information data for the alignment of the orthopaedicimplant calculated according to the computer-implemented method 300described above, and to then use this calculated alignment informationdata, at step 420, to select an orthopaedic implant from a group ofavailable orthopaedic implants.

In one embodiment, the group of available orthopaedic implants relatesto a group of generic, commercially available implants, which have beenmanufactured for the purpose of providing implants to fit a range ofpatients. It will be appreciated each implant within the group ofgeneric orthopaedic implants has structural parameter data that can beused in the computer-implemented method 400 to enable an operator suchas a surgeon, to compare the alignment information data of the patientwith the known structural parameter data of the generic orthopaedicimplants to aid in the selection of an orthopaedic implant of mostappropriate fit with respect to the patient's joint.

Once the most appropriate orthopaedic implant has been selected, theprocessor 1000 is then further controlled by the computer program codeat step 430, to update the database 1030 by virtue of sending, via thedata interface (140, 180), the corresponding alignment information dataassociated with the patient's joint to the database 1030 for use infuture data requests relating to the selection of an orthopaedic implantfor the same patient or another patient.

Aligning an Implant

FIG. 5 shows a computer-implemented method 500 for aligning anorthopaedic implant for a joint of a patient in accordance with anotherembodiment of the present invention. The computer-implemented method 500starts at step 510 where the processor 1000 is controlled by thecomputer program code to receive, via the data interface (140, 180), thealignment information data calculated according to thecomputer-implemented method 300 described above, and to then send thiscalculated alignment information data, via the data interface (140,180), at step 520, to an alignment system (not shown) such as a roboticalignment system, a haptic feedback alignment system, acomputer-assisted alignment system, or any standard or custom-madeinstrument, for use in controlling the alignment system to physicallyalign the orthopaedic implant for the joint of the patient in acorresponding surgical procedure. In this arrangement, the alignmentsystem is connected to the computing device 100 by virtue of a wirednetwork, such as a wired Ethernet™ network or a wireless network, suchas a Bluetooth™ network or IEEE 802.11 network.

In one embodiment, the calculated alignment information data is sentdirectly to the alignment system, via the data interface (140, 180), byvirtue of a direct network connection over a wide area network (WAN),such as the Internet 230 or private WAN.

In one embodiment, the alignment information data is transferred to thealignment system indirectly in the form of a robotics file (not shown)comprising the alignment information data as instructions forcontrolling the alignment system to perform the alignment of theorthopaedic implant for the joint. The robotics file may be transferredto an operator of the alignment system via electronic mail or filetransfer process (FTP) over the Internet 230 or private WAN.

In one embodiment, the robotics file is loaded onto one or more storagemedia (not shown) such as, for example, CD-ROM disks, floppy disks, tapecassettes, or USB memory sticks, and physically transferred to theoperator of the alignment system for direct input into the alignmentsystem.

Modelling an Alignment of an Implant

FIG. 6 shows a computer-implemented method 600 for modelling thealignment of an orthopaedic implant for a joint of a patient inaccordance with another embodiment of the present invention. Thecomputer-implemented method 600 starts at step 610, by deriving thepatient data from the patient specific information data according to thecomputer-implemented method 300 described above. The processor 1000 isthen further controlled by the computer program code to calculate atstep 620, 3D model data of the joint according to the alignmentinformation data. The 3D model data when viewed as a graphicalrepresentation on the display device 1020 provides a schematic dynamic3D model of the joint, which can then be manipulated as desired by, anoperator, such as a surgeon, and used to enable the operator tovisualize the effect and dynamics of the orthopaedic implant inposition.

In one embodiment, the processor 1000 is controlled by the computerprogram code to calculate, at step 630, a set of possible alignmentconfigurations according to the alignment information data and thepatient acquired data 58. The calculated set of possible alignmentconfigurations thus takes into consideration the 3D model and the one ormore post-implant activities the patient wishes to engage in after theorthopaedic implant has been fitted to the joint to establish alignmentconfigurations that would allow the patient to perform such post-implantactivities. By then taking into consideration the post-implantactivities preference data relating to the patient's preference forperforming the post-implant activities, the processor 1000 is furthercontrolled by the computer program code, at step 640, to select analignment configuration from the set of possible alignmentconfigurations calculated above according to the post-implant activitiespreference data. As a result, the selected alignment configuration whenviewed as a graphical representation on the display device 1020 enablesthe operator to visualize the joint of the patient and visualize how theorthopaedic implant can be aligned relative to the joint to achieve thedesired post-implant activities.

Selecting an Implant from a Group of Implants According to 3D Model Data

FIG. 7 shows a computer-implemented method 700 for selecting anorthopaedic implant for a joint of a patient from a group of orthopaedicimplants in accordance with another embodiment of the present invention.The computer-implemented method 700 starts by deriving the patient datafrom the patient specific information data according to steps 310 and320, and then uses the patient data to calculate the actual 3D modeldata of the joint according to step 720.

The processor 1000 is then further controlled by the computer programcode to calculate, at step 730, preferred 3D model data of the jointaccording to the patient data. In this step, a deterministic model ofthe joint is developed when the simulation is performed by an operatoraccording to the above computer-implemented method 700 to produce asimulation model of a “preferred” joint that takes into considerationboth the dynamic characteristics and the static characteristicsdescribed above. The processor 1000 is further controlled by thecomputer program code, at step 740, to select an orthopaedic implantfrom a group of orthopaedic implants according to the actual 3D modeldata and the preferred 3D model data. In this step, the operator can usethe preferred 3D model data of the joint in order to select anorthopaedic implant that most closely recreates the results proposed bythe preferred 3D model data.

In one embodiment, the processor 1000 is controlled by the computerprogram code to receive, via the data interface (140, 180), at step 750,patient acquired data 58, being indicative of the one or more desiredpost-implant activities, in which the patient acquired data comprisespost-implant activities preference data. By then taking intoconsideration the post-implant activities preference data relating tothe patient's preference for performing the post-implant activities, theprocessor 1000 is further controlled by the computer program code, atstep 760, to calculate the preferred 3D model data of the jointaccording to the post-implant activities preference data. As a resultthe preferred 3D model data takes into consideration the patient'sdesired post-implant activities to produce a simulation model of thejoint that would enable the patient to perform their desiredpost-implant activities.

In one embodiment, the computer-implemented method 700 is taken one stepfurther to take into consideration library alignment configuration datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities or libraryalignment configuration data relating to a group of patients fitted withan orthopaedic implant for performing at least one of the one or moredesired post-implant activities. In this embodiment, the processor 1000is controlled by the computer program code, at step 770, to load fromthe database 1030, the library alignment configuration data, and to thenselect the orthopaedic implant according to the library alignmentconfiguration data. In this step, the preferred 3D model of the joint isfurther calculated based on an improvement of the actual 3D model dataaccording to a comparison with the known library alignment configurationdata.

As a result of the embodiments, the preferred 3D model data of the jointwhen viewed as a graphical representation on the display device 1020enables the operator to visualize and compare how the preferred 3D modelof the joint will align with selected orthopaedic implants from thelibrary alignment configuration data and how the orthopaedic implantsare likely to perform functionally for specific post-implant activities.An operator is thus able to select the orthopaedic implant from thegroup of available orthopaedic implants that would best suit the patientto enable them to perform the desired post-implant activities accordingto their desired preference.

In use, the above described modelling technique is applied to testingpredetermined orthopaedic implants at predetermined alignmentconfigurations. The simulation file can then be viewed as, for example,a graphical representation, by the operator who can then extractinformation regarding the functional kinematic response on the patient'sjoint fitted with the predetermined orthopaedic implant and thepredetermined alignment configuration. The surgeon can then choose torun another simulation with a different predetermined orthopaedicimplant and/or a different predetermined alignment configuration inresponse to information regarding, for example, stress on the patient'sjoint based on the first simulation operation. This process is thenrepeated, as desired, until the surgeon is happy with the predeterminedimplant and the predetermined alignment configuration.

It will be appreciated that the graphical representation is not limitedto displaying a schematic 3D model of the joint, but may in variousembodiments, also include graphical representations of a model of thejoint using a predetermined orthopaedic implant, a model of thepatient's joint using a predetermined alignment configuration, or agraphical response curve showing such information as joint stress inresponse to the choice or orthopaedic implant and choice of alignmentconfiguration. The graph 40 of FIG. 12 is an example of a response curveshowing the level of strain on a model of a joint.

Manufacturing Parameters Orthopaedic Implant

FIG. 8 shows a computer-implemented method 800 for developingmanufacturing parameters for manufacturing an orthopaedic implant for ajoint of a patient having an orthopaedic implant articulation surface inaccordance with another embodiment of the present invention. Thecomputer-implemented method 800 starts, at step 810, by deriving thepatient data from the patient specific information data according tosteps 310 and 320. At step 820, the processor 1000 is then furthercontrolled by the computer program code to calculate design data for theorthopaedic implant according to the patient data. In this step, thedesign data relates to the structural parameters of the wholeorthopaedic implant including the articulation surface of theorthopaedic implant. In other embodiments, the design data only relatesto structural parameters of the articulation surface.

At step 830, the processor 1000 is further controlled by the computerprogram code to calculate the manufacturing parameters, such as a 3D CADmodel, for manufacturing the orthopaedic implant according to the designdata. The developed manufacturing parameters can then be used in themanufacture of the orthopaedic implant using one or more suitablemanufacturing processes. Such manufacturing processes may comprise anadditive manufacturing process, such as stereolithography (SLA),selective laser sintering (SLS), direct metal laser sintering (DMLS),electron beam melting (EBM), and 3D printing (3DP), or a subtractivemanufacturing process, such as biomachining, abrasive flow machining,abrasive jet machining, milling, laser cutting, and water jet cutting.

In one embodiment, the computer-implemented method 800 is taken one stepfurther to take into consideration the one or more desired post-implantactivities of the patient. In this embodiment, the processor 1000 isfurther controlled by the computer program code, at step 840, toreceive, via the data interface (140, 180), the patient acquired data58, being indicative of the one or more desired post-implant activities,and comprising the post-implant activities preference data, and to thencalculate, at step 850, post-implant design data of the orthopaedicimplant based on the post-implant activities preference data. In thisstep, the post-implant design data defines an orthopaedic implant, andin particular the articulation surface of the orthopaedic implant thatwould enable the patient to perform the desired post-implant activitiesaccording to their preference for performing the post-implant activitiesonce the orthopaedic implant has been fitted. The processor 1000 is thenfurther controlled by the computer program code, at step 860, tocalculate the manufacturing parameters for manufacturing the orthopaedicimplant further according to the post-implant design data.

In one embodiment, the computer-implemented method 800 is taken one stepfurther to take into consideration library design data relating to thedesign data for a group of available orthopaedic implants for performingat least one of the one or more desired post-implant activities ordesign data relating to a group of patients fitted with an orthopaedicimplant for performing at least one of the one or more desiredpost-implant activities. In this embodiment, the processor 1000 iscontrolled by the computer program code, at step 870, to load from thedatabase 1030, the library design data, and to then calculate themanufacturing parameters for manufacturing the orthopaedic implantfurther according to the known library design data.

As a result of the above embodiments, an operator is thus able todevelop manufacturing parameters to be used in the manufacture of anorthopaedic implant for the joint of the patient based on a comparisonof the structural parameters of the patient's joint and the knownfunctional capabilities of the group of available orthopaedic implantsin the database 1030 that would best suit the patient to enable them toperform the desired post-implant activities according to their desiredpreference.

Custom Articulation

FIG. 9 shows a computer-implemented method 900 for developingmanufacturing parameters for manufacturing a custom articulation (notshown) for attachment to an orthopaedic implant in accordance withanother embodiment of the present invention. The custom articulation ispart of the orthopaedic implant (generally attached, mechanicallylocked, or adhered thereto) having the manufacturing parameters asdeveloped above, will best enable the joint to perform desiredfunctional outcomes. The computer-implemented method 900 starts at step910, by receiving the design data calculated for the orthopaedic implantaccording to the computer-implemented method 800 as described above. Atstep 920, the processor 1000 is then further controlled by the computerprogram code to calculate manufacturing parameters for manufacturing thecustom articulation according to the design data. In this step, themanufacturing parameters for the customized articulation implant takeinto consideration the design data for the orthopaedic implant, inparticular the design data that relates to the articulation surface ofthe orthopaedic implant, and then uses this data to develop anarticulation surface for the customized implant that complements thearticulation surface of the orthopaedic implant. The developedmanufacturing parameters can then be used in the manufacture of thecustom articulation using one or more of the manufacturing processeslisted above.

As a result of the above embodiments, an operator is thus able todevelop manufacturing parameters to be used in the manufacture of acustomized articulation implant having a complementary articulationsurface to the articulation surface of the manufactured orthopaedicimplant described above. In this sense, the orthopaedic implant and thecustom articulation, once attached, adhered, or mechanically locked tothe corresponding implant (for example, a tibial tray), can be fitted tothe joint of the patient to enable the patient to perform the desiredpost-implant activities according to their desired preference.

Patient Specific Jig

FIG. 10 shows a computer-implemented method 1200 for developingmanufacturing parameters for manufacturing a patient specific jig (notshown) for use in preparing a joint in readiness for aligning anorthopaedic implant to the joint of a patient in accordance with anotherembodiment of the present invention. In this embodiment, themanufacturing parameters are in the form of a computer file for use by acomputer navigation software system or a robotics file for use by arobotics system. The patient specific jig is a cutting guide devicewhich can be mounted to a particular bone of the joint for the purposeof guiding a surgeon during the resectioning, cutting of forming holesin the bones of the joint in order to align the orthopaedic implant withthe joint in the same spatial orientation which provides the bestoverall performance for a particular post-implant activity.

The computer-implemented method 1200 starts, at step 1210, by derivingthe patient data from the patient specific information data according tosteps 310 and 320. At step 1220, the processor 1000 is then furthercontrolled by the computer program code to calculate jig design data forthe patient specific jig according to the patient data. At step 1230,the processor 1000 is then further controlled by the computer programcode to calculate manufacturing parameters for manufacturing the patientspecific jig according to the jig design data. The developedmanufacturing parameters can then be used in the manufacture of thepatient specific jig using one or more of the manufacturing processeslisted above. As a result, the jig design data relies on the patientdata to establish a patient specific jig that can conform to the joint.

FIGS. 14 to 20 illustrate various graphical representations of predictedcomputer simulation results for a knee joint of a patient based on thealignment information data calculated using the computer-implementedmethod 300 described above.

FIGS. 14A, 14B and 14C illustrate simulated kinematics results for thechange in varus angle (in degrees) of a knee joint as the knee bends orflexes to represent the patient going through the steps of transitioningfrom a generally standing position, namely a flexion angle of 0 degrees(see FIG. 14AI), to a generally kneeling position, namely a flexionangle of 100 degrees (see FIG. 14C).

FIGS. 15A, 15B and 15C illustrate simulated kinematics results for thechange in quadricept force (in newtons) of a knee joint as the kneebends or flexes to represent the patient going through the steps oftransitioning from a generally standing position, namely a flexion angleof 0 degrees (see FIG. 15A), to a generally kneeling position, namely aflexion angle of 100 degrees (see FIG. 15C).

FIGS. 16A, 16B and 16C illustrate simulated kinematics results for thechange in internal-external rotation (in degrees) of a knee joint as theknee bends or flexes to represent the patient going through the steps oftransitioning from a generally standing position, namely a flexion angleof 0 degrees (see FIG. 16A), to a generally kneeling position, namely aflexion angle of 100 degrees (see FIG. 16C).

FIGS. 17A, 17B and 17C illustrate simulated kinematics results for thechange in patella lateral shear force (in newtons) of a knee joint asthe knee bends or flexes to represent the patient going through thesteps of transitioning from a generally standing position, namely aflexion angle of 0 degrees (see FIG. 17A), to a generally kneelingposition, namely a flexion angle of 120 degrees (see FIG. 17C).

FIGS. 18A, 18B and 18C illustrate simulated kinematics results for thechange in internal-external rotation (in degrees) of a knee joint as theknee bends or flexes to represent the patient going through the steps oftransitioning from a generally standing position, namely a flexion angleof 0 degrees (see FIG. 18A), to a generally crouching or squattingposition, namely a flexion angle of around 112.5 degrees (see FIG. 18C).The results illustrate the degree of variation in the of theinternal-external rotation at three different varus/valgus anglesrelative to the primary mechanical axis of the knee joint.

FIGS. 19A and 19B illustrate simulated kinematics results for the changein various parameters of a knee joint as the knee bends or flexes torepresent the patient going through the steps of transitioning from agenerally standing position, namely a flexion angle of 0 degrees, to agenerally kneeling position, namely a flexion angle of around 140degrees. In this arrangement, an operator, such as a surgeon, has theability to predict simulated kinematics results for the knee joint of apatient by adjusting the various parameters associated with the kneejoint, such as the varus angle (in degrees), the internal-externalrotation (in degrees) and slope (in degrees). For example, in FIG. 19A,the varus angle (in degrees), and the internal-external rotation (indegrees) of the femur and tibia are all set to zero, as is the slope ofthe tibia. However, when the varus angle of the femur is adjusted to 3.0degrees (see FIG. 19B, there are noticeable differences in the medial(see the flexion facet centre (FFC) results in FIG. 19B image A), theinternal-external rotation angle of the knee joint (see FIG. 19B imageB), the ligament strain on the lateral collateral ligament (LCL), theanterior medial collateral ligament (anterior MCL) and the posteriormedial collateral ligament (posterior MCL) (see FIG. 19B image D), andthe patella medial/lateral shear force (in newtons) (see FIG. 19B imageE). In this sense, by adjusting the various parameters associated withthe knee joint, the surgeon is able to predict the optimum results foraligning an orthopaedic implant relative to the joint of the patient.

FIG. 20A illustrates a patient survey obtained for a group of eightpatients, each fitted with an orthopaedic implant, stored as libraryalignment information data and library alignment configuration data inthe database 1030. The results of the survey show the change ininternal-external rotation (in degrees) of their respective left andright knee joints as the knees bend or flex to represent the patientsgoing through the steps of transitioning from a generally standingposition to a generally crouching or squatting position. Based on theresults of the left knees studied, all exhibit generally the sameinternal-external rotation with respect to the fitted orthopaedicimplant. For the right knees studied, the right knee of one patient(pat004) shows an abnormal internal-external rotation when compared withthe others.

FIG. 20B illustrates a corresponding set of results obtained from thesame group of eight patients showing the change in patella shear force(in newtons) of the left and right knee joints of the eight patients astheir respective knees bend or flex to represent the patients goingthrough the steps of transitioning from a generally standing position toa generally crouching or squatting position. Based on the results of theleft knees studied, all but one of the left knees (pat2ERyanLeftTECHSIM)exhibits generally the same patella shear force with respect to thefitted orthopaedic implant. For the right knees studied, the right kneeof one patient (pat008) shows an abnormal patella shear force whencompared with the others.

Based on the results of FIG. 20A and FIG. 20B, an operator, such as asurgeon, can observe the effects of a particular orthopaedic implantwhen fitted to each of the eight patients and how it influences thecorresponding patients' biomechanical performance. The surgeon can thenuse these results to predict how the same orthopaedic implant whenfitted to the patient will influence their biomechanical performancethrough a comparison of the alignment information data and alignmentconfiguration of the patient with the corresponding library data storedin the database 1030.

FIGS. 21 to 23 illustrate various graphical representations of predictedcomputer simulation results for a hip joint of a patient based on thealignment information data calculated using the computer-implementedmethod 300 described above.

FIGS. 21A, 21B and 21C illustrate simulated kinematics results for thechange in hip load (magnitude and direction) of the left and right hipjoints of a patient as the patient goes through the steps oftransitioning from a generally standing position (see FIG. 21A), to agenerally crouching position (see FIG. 21B), and back to the generallystanding position (see FIG. 21C). In this example, the left hip jointsimulated orthopaedic implant comprises the stem of the femur and thecorresponding acetabular cup into which the femoral stem is received.

FIGS. 22A, 22B and 22C illustrate simulated kinematics results for theplacement (in degrees) of a simulated orthopaedic implant in the form ofan acetabular cup 70 and a femur 75 with a femoral stem 75, in which theacetabular cup 70 of the hip joint has an angle of inclination of 45degrees and 25 degrees anteversion with reference to the anterior pelvicplane. The direction of the hip load is indicated by arrow 80 in each ofthe four images (A, B, C and D) in both FIGS. 22A and 22B.

FIG. 22A corresponds to the patient fitted with the simulatedorthopaedic implant in a generally standing position, and FIG. 22Bcorresponds to the patient in a generally sitting position. The fourimages (A, B, C, D) in each of FIGS. 22A and 22B correspond to differentviews of the same hip joint as the patient transitions between thestanding and sitting position.

FIG. 22C shows a corresponding 2D plot that is representative of theinterior articulation surface of the cup 70, and of the resultant hipload 80, which is shown as a trace line 85 that is produced by thefemoral stem 75A acting on the articulation surface of the cup 70 as thepatient goes through the steps of transitioning from a generallystanding position (see FIG. 22A) to a generally sitting position (seeFIG. 22B). The trace line 85 corresponds to the hip load (including themagnitude and direction of the hip load). The centre of the 2D plotcorresponds to the polar region of the articulation surface of the cup70, while the outer periphery of the 2D plot corresponds to the edge ofthe articulation surface of the cup 70.

FIGS. 23A, 23B and 23C illustrate simulated kinematics results for theplacement (in degrees) of a simulated orthopaedic implant in the form ofan acetabular cup 70 and a femur 75 with a femoral stem 75, in which theacetabular cup 70 of the hip joint has an angle of inclination of −35degrees and 15 degrees anteversion (see FIG. 23A) with reference to theanterior pelvic plane. The direction of the hip load is indicated byarrow 80 in each of the four images (A, B, C and D) in both FIGS. 23Aand 23B.

FIG. 23C shows a corresponding 2D plot that is representative of theinterior articulation surface of the cup 70, and of the resultant hipload 80, which is shown as a trace line 90 that is produced by thefemoral stem 75A acting on the articulation surface of the cup 70 as thepatient goes through the steps of transitioning from a generallystanding position (see FIG. 23A) to a generally sitting position (seeFIG. 23B). The trace line 90 corresponds to the hip load (including themagnitude and direction of the hip load). The centre of the 2D plotcorresponds to the polar region of the articulation surface of the cup70, while the outer periphery of the 2D plot corresponds to the edge ofthe articulation surface of the cup 70.

The simulated results of FIG. 22C and FIG. 23C show that the trace line85 in FIG. 22C is generally closer to the centre of the 2D plot (thepolar region of the articulation surface) than trace line 90 (see FIG.23C). In addition, the trace line 90 also extends slightly furthertowards the outer periphery of the 2D plot than the trace line 85.

It will be appreciated that the simulated kinematics results of FIGS. 14to 23 are not limited to those shown, but may include other dynamicmetrics.

Implant Design Data

FIG. 11 shows a computer-implemented method 1300 for calculating implantdesign data for a group of orthopaedic implants in accordance withanother embodiment of the present invention. The computer-implementedmethod 1300 starts at step 1310 where the processor 1000 is controlledby the computer program code to receive, via the data interface (180,140), patient library data, corresponding to the alignment informationdata of multiple orthopaedic implants of multiple patients provided bythe computer-implemented method 300 described above. At step 1320, theprocessor 1000 is further controlled by the computer program code toreceive, via the data interface (180, 140), implant range data,indicative of one or more subsets of the patient library data selectedaccording to a user input request. At step 1330, the processor 1000 isfurther controlled by the computer program code to calculate the implantdesign data for the group of orthopaedic implants according to thepatient library data and the implant range data. Revised patient librarydata is calculated on the basis of filtering the patient library dataaccording to the implant range data. The implant design data for thegroup or orthopaedic implants can then be calculated according to astatistical analysis of the revised patient library data using anappropriate statistical analysis method. A number of statisticalanalysis methods are available for such purpose including, but notlimited to, such methods as regression analysis and least squaresanalysis.

In one embodiment, the operator can choose to filter the patient librarydata further according to patient satisfaction data relating to a numberof satisfied patients selected from a group of patients fitted with anorthopaedic implant for performing certain post-implant activities. Thepatient satisfaction data may relate to the overall performance of theparticular orthopaedic implant with respect to its biomechanicalperformance when performing the post-implant activity or activities, thedegree of comfort experienced by the patient when performing thatparticular post-implant activity, and the degree of freedom of motionwhen performing that particular post-implant activity. Therefore, if anumber of patients were satisfied with a particular orthopaedic implantand its biomechanical performance then this result can be indicatedgraphically on a chart, to alert the operator to the potential that thisorthopaedic implant has in relation to a patient looking to receive theorthopaedic implant.

In one embodiment, the operator can choose to filter the patient librarydata according to the number of orthopaedic implants selected from agroup of orthopaedic implants for performing at least one of the one ormore post-implant activities of the patient.

In one embodiment, the operator can choose to filter the patient librarydata according to the number of orthopaedic implants of a particularsize that are available to the patient to enable them to perform atleast one of the one or more post-implant activities.

FIG. 24 illustrates an exemplar graphical representation that anoperator, such as a surgeon, can use to identify an orthopaedic implantthat is the most appropriate fit for the joint of a patient that willenable the patient to perform one or more of the desired post-implantactivities. Firstly, the size of the patient's joint is determined basedon the anterior-posterior (A-P) and median-lateral (M-L) dimensions ofthe joint. The dimensions of the joint are then plotted against a rangeof orthopaedic implants (for example, X, Y and Z), obtained from thecorresponding library data stored in the database 1030, to identify themost appropriately sized orthopaedic implant for the patient. In thisexample, and as shown in FIG. 24A, the A-P and M-L dimensions of thejoint are sizes 3 and 3, respectively, such that the most appropriatelysized orthopaedic implant is Z. Orthopaedic implants Z, ZA, ZB, and ZCall have the same A-P and M-L dimensions as the joint, but theirarticulation surfaces differ by varying degrees. For example, the depthof the trochlear for orthopaedic implant Z may be greater than that fororthopaedic implants ZA, ZB, and ZC to provide stability to the jointonce implanted.

As shown in FIG. 24A, the selected orthopaedic implants (Z, ZA, ZB, andZC) correspond to an associated post-implant activity (for example,tennis, golf, skiing, or any defined kinematic propositions) by virtueof the difference in the associated articulation surface. For example,orthopaedic implant ZA comprises an articulation surface that istranslation limiting, making it suitable for such activities as tennis,while orthopaedic implant ZB has an articulation surface that isrotation accommodating, thereby making it suitable for such activitiesas golf. Assuming the patient has a greater desire to play tennis overthe other two post-implant activities (golf and skiing), the surgeonwould opt for orthopaedic implant ZA, as indicated in FIG. 24B.

FIG. 25 illustrates another exemplar graphical representation that anoperator, such as a surgeon, can use to identify a range of orthopaedicimplants for both left and right knee joints, stored within the database1030 as patient library data, which fall within a certain size range.Firstly, the desired size range of left and right orthopaedic implantsare input as implant range data according to both the anterior-posterior(A-P) and median-lateral (M-L) dimensions of each orthopaedic implant.In this example, the size range selected includes sizes from 1 to 6 forboth left (L) and right (R) orthopaedic implants, respectively. Thecorresponding plot provides a bell curve as shown in FIG. 25.

As indicated in the plot, post-implant activities (tennis, golf, skiing,football, or any defined kinematic propositions) are also taken intoconsideration when generating such results, producing a 3D bell curve.In this example, and as shown in FIG. 25, the A-P and M-L dimensions ofthe right (R) orthopaedic implant of size 3, are the same as the A-P andM-L dimensions for the corresponding right (R) orthopaedic implants 3A,3B, 3C, 3D, but the articulation surfaces of each implant differs, asdescribed in the example above (see FIG. 24), where 3A has anarticulation surface that is suitable for playing tennis, 3B for golf,3C for skiing, and 3D for football.

By being able to identify orthopaedic implants of a particular sizerange, it is possible for a customer to create, for example, aninventory of orthopaedic implants to suit one or more sectors of thegeneral public.

It will be appreciated that the patient library data and implant rangedata are not limited to those described above, but that a range ofpatient data or orthopaedic implant data may be stored in the database1030 for future reference.

Advantages

The various embodiments described above provide a range of advantagesincluding:

Providing improved patient specific alignment by considering a range ofpossible alignment configurations before the implant operation. Once animproved patient specific alignment has been identified, a surgeon canchoose a modern and precise computer assisted surgical technique, suchas a customized cutting guide or surgical navigation, to deliver thisalignment with the required precision.

Providing improved patient specific alignment by considering a nominalalignment configuration, determined by the operator as being analignment configuration that would be suitable for the patient toperform one or more of their desired post-implant activities.

Providing patient specific improvement of the choice of orthopaedicimplant available. A person skilled in the art would be aware that thereare a number of predetermined orthopaedic implants commerciallyavailable with each implant having slight differences. The alignmentinformation data and alignment configuration data calculated accordingto the embodiments described above can be presented in various forms,such as, for example, graphical representations, to enable a surgeon toselect the most appropriate orthopaedic implant with respect to thepatient's joint and their desired post-implant activities.

Enabling the specification of a specific articulator insert (for examplea tibial insert for a knee) comprising a customized implant with anarticulation surface having a shape derived from the patient specificimprovement, and the alignment/placement of that patient specificarticulator insert relative to the knee joint.

The provision of the simulated results in the form of, for example, oneor more data files, enables the manufacture of a physical product:

Custom patient specific jig, namely a cutting guide that can be placedon the joint of a patient during the operation to physically guide thesurgeon.

Custom made computer navigation file, essentially an interactivedemonstration specific to the implant operation with respect to thepositioning and placement of an orthopaedic implant relative to thejoint of a patient.

Custom made robotics file that can be used by an alignment system toalign an orthopaedic implant relative to the joint of a patient.

Customized implant with an articulation surface having a shape derivedfrom the patient specific improvement process. The custom articulationcan then be attached, adhered, or mechanically locked to the implant ofan articulator insert (such as a tibial tray for a tibial insert).

Complete custom made orthopaedic implants with patient specific customarticulation surface.

Use

A step by step general example of a preferred embodiment of the presentinvention is set out below which provides a virtual kinematic simulator:

A 3D image of the bone geometry of a knee joint in the form of a CT orMRI image is acquired by usual means and converted to a DICOM file by anoperator.

The DICOM file is communicated to the computing device 100 using, forexample, a client computing device 220 connected to the computing device100 via the Internet 230 or a private WAN.

The DICOM file is filtered and segmented to remove unwanted data.

Anatomical landmarks are identified from the DICOM file.

Surgery is planned for a generic default position, such as mechanicalaxis alignment for the knee, and a chosen implant design. Thisspecifically involves aligning the implants such that the defaultposition would be achieved if no improvement occurred.

A deterministic patient specific rigid body mechanics simulation isperformed by the computing device 100,

A deterministic model is developed when a simulation is performed on aspecific implant position to produce a simulated result.

The operator can view the simulation result of the default position withchosen orthopaedic implants in the form of, for example, a graphicalrepresentation, by using a client computing device 220 connected to thecomputing device 100 via the Internet 230.

The operator can then modify the position from the previous defaultand/or modify the chosen orthopaedic implant and view new simulationresults. The factors that influence the modification are thoseunderstood by the operator, based on the operator's skills andexperience. These could be patient specific or more general, forexample, it could relate to a specific patient requirement for moreexternal rotation of the femoral component, or it could be more simply arecognition that in all the extension is achieved by increasing thedistal femoral resection.

Once the operator, such as a surgeon, is satisfied with the simulation,the surgeon can then order a patient specific surgical delivery planusing a client computing device 220 connected to the computing device100 via the Internet 230.

A surgical plan delivery tool is generated: this includes an actualpatient specific jig, namely, a cutting guide that would be pinned tothe bone and used to cut through, and also provide visual navigationinstructions that the surgeon can follow.

A step by step general example of a preferred embodiment of the presentinvention is set out below, which looks at a goal driven improvementthat provides the simulation result in the form of, for example, agraphical representation, which includes implant design, position andarticulation:

A 3D image of a knee joint in the form of a CT or MRI image is acquiredby usual means and converted to a DICOM file by a surgeon.

The DICOM file is communicated to the computing device 100 using, forexample, a client computing device 220 connected to the computing device100 via the Internet 230 or a private WAN.

The DICOM file is filtered and segmented to remove unwanted data.

Anatomical landmarks are identified from the DICOM file.

Damage on the articular surfaces is identified and corrected byinterpolation of shape from non damaged articular surfaces to generate avirtual corrected natural model.

A deterministic patient specific rigid body mechanics simulation isperformed by the computing device 100, specifically processor 1000.

The design, shape and articulation of the orthopaedic implants could be:

A. an existing design.

B. a combination of existing design and custom made components

C. a completely custom made orthopaedic implant.

The operator, such as a surgeon and/or implant manufacturer, can definean acceptable range of implant positions within six degrees of freedom,for example (whilst maintaining distal femoral and posterior condylaroffset, distal femoral cut—three degrees valgus to three degrees varus,distal femoral cut—zero to five degrees flexion, rotation—three degreesinternal to three degrees external in regards to the trans-epicondylaraxis).

Using, for example, a client computing device 220 connected to thecomputing device 100 via the Internet 230 or a private WAN, the surgeoncan view the simulation result of a default position with chosenorthopaedic implants in the form of, for example, a graphicalrepresentation.

The surgeon can then modify the position from the previous defaultand/or modify the chosen implant and view new simulation results. Thefactors that influence the modification are those understood by thesurgeon, based on the surgeon's skills and experience. These could bepatient specific or more general, for example, it could relate to aspecific patient requirement for more external rotation of the femoralcomponent, or it could be more simply recognition that in all, theextension is achieved by increasing the distal femoral resection.

Once the surgeon is satisfied with the simulation, the surgeon can thenorder a patient specific surgical delivery plan using, for example, aclient computing device 220 connected to the computing device 100 viathe Internet 230 or a private WAN.

A surgical plan delivery tool is generated: this includes an actualpatient specific jig that would be pinned to the bone and used to cutthrough, and also provide visual navigation instructions that thesurgeon can follow.

A step by step general example of a preferred embodiment of the presentinvention is set out below, which looks at a multi objective goal-drivenimprovement directed towards patient specific functionality goals:

Patient functionality objectives, namely, desired post-implantactivities, and the patient's preference for the post-implant activitiesare captured in lay language by the questionnaire.

Functionality goals are then ranked in a hierarchy by the patientaccording to their preference for performing the post-implantactivities, and by the surgeon: for example (the ability to kneel ismost important, the ability to walk up stairs is second most important,the ability to play lawn bowls is third most important, and so on).

A 3D image of the knee joint of the patient in the form of, for example,a CT or MRI image, is acquired by usual means and converted to a DICOMfile by an operator.

The DICOM file is communicated to the computing device 100 using, forexample, a client computing device 220, via the Internet 230 or aprivate WAN.

The DICOM file is filtered and segmented to remove unwanted data.

Anatomical landmarks are identified from the DICOM file.

A deterministic patient specific rigid body mechanics simulation isperformed by the computing device 100, specifically processor 1000, andan appropriate orthopaedic implant is chosen by the operator. Thedesign, shape and articulation of the orthopaedic implant could be:

A. an existing design.

B. a combination of existing design and custom made components.

C. a completely custom made orthopaedic implant.

A multi objective goal-driven improvement is performed as follows:

-   -   i. Surgeon and/or implant manufacturer define an acceptable        range of implant positions within six degrees of freedom for all        parameters: for example (whilst maintaining distal femoral and        posterior condylar offset, distal femoral cut—three degrees        valgus to three degrees varus, distal femoral cut—zero to five        degrees flexion, rotation—three degrees internal to three        degrees external in regards to the trans-epicondylar axis).    -   ii. Patient functionality objectives, namely, desired        post-implant activities, and the patient's preference for the        activities are transposed by the computing device 100 into        numerical goals: for example (“I want to be able to play tennis”        becomes “maximum possible external rotation of the femur,        relative to the tibia, in extension is required”).    -   iii. Patient specific numerical goals that exist outside the        parameters created by the surgeon and manufacturer are excluded.    -   iv. Patient specific numerical goals that exist inside the        parameters created by the surgeon and manufacturer are included.

An improved position is generated, based on the simulation result, whichbest satisfies the multiples of objectives.

The surgeon can then view the simulation result of the default positionwith chosen orthopaedic implants in the form of, for example, agraphical representation, using a client computing device 220 connectedto the computing device 100 via the Internet 230 or private WAN.

The surgeon can then modify the position from the previous defaultand/or modify the chosen orthopaedic implant and view new simulationresults. The factors that influence the modification are thoseunderstood by the surgeon, based on the surgeon's skills and experience.These could be patient specific or more general.

Once the surgeon is satisfied with the simulation, the surgeon can thenorder a patient specific surgical delivery plan using, for example, aclient computing device 220 connected to the computing device 100 viathe Internet 230 or private WAN.

A surgical plan delivery tool is generated: this includes an actualpatient specific jig that would be pinned to the bone and used to cutthrough, and also provide visual navigation instructions that thesurgeon can follow.

It is emphasized that ideal simulation models correspond to a variety ofdifferent post-implant activities and actions ranging from simpleeveryday movements such as climbing up and down a staircase and gettinginto and out of a car, to more rigorous activities such as playingnetball and skiing.

It will be appreciated by those skilled in the art that the patientspecific alignment will provide patients with significantly improvedfunctional outcomes. This is generally done by the computer-implementedmethods described above which:

Pre-operatively create accurate patient specific models of individualpatients.

Improves the alignment for each patient to meet their individualfunctional requirements.

Dynamic modelling techniques have been shown to be a valuable tool forthe virtual prediction of joint kinematics, loading and articulationbehaviour. When applied to joint replacements, dynamic modelling hasbeen used to distinguish the generalised effects that design variationshave on joint kinematics, joint loading and joint articulation behaviourbefore needing to test these designs on patients. This is valuable whencomparing the general features and benefits of different designs.

The simulation of patient specific scenarios by inputting patientspecific parameters, rather than generalised ‘average’ parameters, givesrise to predictions that are relevant to a specific patient in aspecific “real life” scenario.

This is especially advantageous as applications are made for thesurgical delivery plan to be accessed directly from a surgical theatreusing, for example, a client computing device 220 connected to thecomputing device 100 via the Internet 230 or a private WAN.

Other advantages of the invention include:

Providing a full biomechanical simulation using inverse dynamics withrigid body mechanics simulations to predict a post operative range ofmotion, joint kinematics, joint loading, joint behaviour, friction, andfunctionality results in a certain situation. For example: if a certainorthopaedic implant X is placed in a particular patient Y in specificorientation Z, the result can be accurately predicted. Further, alldesirable ranges of positions and shapes can be tested/sampled.

Providing prediction of patient specific natural kinematics by using aninverse dynamics with rigid body mechanics simulation to predict the nonpathologic natural range of motion, kinematics, loading, friction andfunctionality results. Setting this as the goal of the surgery and thenusing a goal driven improvement to achieve the closest possiblerepresentation via selection of implant design, shape, size,articulation and position.

Satisfying patient specific functional goals, namely post-implantactivities, by translating the patient lay language from thequestionnaire into numerical goals for a multi objective improvementusing an inverse dynamics with rigid body mechanics simulation.Achieving the improved position in the closest manner possible viaselection of implant design, shape, size, articulation and position.

Providing a surgeon access to the simulation environment and providingthe opportunity to pre-operatively and specifically vary the parametersand boundaries and observe the resultant impact to the patient.

It is emphasized that, although the examples and embodiments given aboveare directed towards knee replacements, the same general technology canbe applied to hip replacements in a similar manner. Accordingly, it willbe appreciated by those skilled in the art that the general principlesabove can be applied to embodiments where the joint is a hip joint.

In other embodiments, other image file-types are used such as STL, JPEG,GIF and TIF image files.

In other embodiments, the general principles above can be applied to allarticulating implantable devices such as, but not limited to: shoulderreplacements, spinal disc replacements, and ankle replacements.

In other embodiments, the general principles above can be applied to allimplantable devices that are used in articulating joints, but where theimplantable device is not itself an articulation replacement, includingbut not limited to: knee anterior cruciate ligament reconstruction andshoulder rotator cuff repair.

Interpretation Wireless:

The invention may be embodied using devices conforming to other networkstandards and for other applications, including, for example other WLANstandards and other wireless standards. Applications that can beaccommodated include IEEE 802.11 wireless LANs and links, and wirelessEthernet.

In the context of this document, the term “wireless” and its derivativesmay be used to describe circuits, devices, systems, methods, techniques,communications channels, etc., that may communicate data through the useof modulated electromagnetic radiation through a non-solid medium. Theterm does not imply that the associated devices do not contain anywires, although in some embodiments they might not. In the context ofthis document, the term “wired” and its derivatives may be used todescribe circuits, devices, systems, methods, techniques, communicationschannels, etc., that may communicate data through the use of modulatedelectromagnetic radiation through a solid medium. The term does notimply that the associated devices are coupled by electrically conductivewires.

Processes:

Unless specifically stated otherwise, as apparent from the followingdiscussions, it is appreciated that throughout the specificationdiscussions utilizing terms such as “processing”, “computing”,“calculating”, “determining”, “analysing” or the like, refer to theaction and/or processes of a computer or computing system, or similarelectronic computing device, that manipulate and/or transform datarepresented as physical, such as electronic, quantities into other datasimilarly represented as physical quantities.

Processor:

In a similar manner, the term “processor” may refer to any device orportion of a device that processes electronic data, e.g., from registersand/or memory to transform that electronic data into other electronicdata that, e.g., may be stored in registers and/or memory. A “computer”or a “computing device” or a “computing machine” or a “computingplatform” may include one or more processors.

The methodologies described herein are, in one embodiment, performableby one or more processors that accept computer-readable (also calledmachine-readable) code containing a set of instructions that whenexecuted by one or more of the processors carry out at least one of themethods described herein. Any processor capable of executing a set ofinstructions (sequential or otherwise) that specify actions to be takenare included. Thus, one example is a typical processing system thatincludes one or more processors. The processing system further mayinclude a memory subsystem including main RAM and/or a static RAM,and/or ROM.

Computer-Readable Medium:

Furthermore, a computer-readable carrier medium may form, or be includedin a computer program product. A computer program product can be storedon a computer usable carrier medium, the computer program productcomprising a computer readable program means for causing a processor toperform a method as described herein.

Networked or Multiple Processors:

In alternative embodiments, the one or more processors operate as astandalone device or may be connected, e.g., networked to otherprocessor(s), in a networked deployment, the one or more processors mayoperate in the capacity of a server or a client machine in server-clientnetwork environment, or as a peer machine in a peer-to-peer ordistributed network environment. The one or more processors may form aweb appliance, a network router, switch or bridge, or any machinecapable of executing a set of instructions (sequential or otherwise)that specify actions to be taken by that machine.

Note that while some diagram(s) only show(s) a single processor and asingle memory that carries the computer-readable code, those in the artwill understand that many of the components described above areincluded, but not explicitly shown or described in order not to obscurethe inventive aspect. For example, while only a single machine isillustrated, the term “machine” shall also be taken to include anycollection of machines that individually or jointly execute a set (ormultiple sets) of instructions to perform any one or more of themethodologies discussed herein.

Additional Embodiments

Thus, one embodiment of each of the methods described herein is in theform of a computer-readable carrier medium carrying a set ofinstructions, e.g., a computer program that are for execution on one ormore processors. Thus, as will be appreciated by those skilled in theart, embodiments of the present invention may be embodied as a method,an apparatus such as a special purpose apparatus, an apparatus such as adata processing system, or a computer-readable carrier medium. Thecomputer-readable carrier medium carries computer readable codeincluding a set of instructions that when executed on one or moreprocessors cause a processor or processors to implement a method.Accordingly, aspects of the present invention may take the form of amethod, an entirely hardware embodiment, an entirely software embodimentor an embodiment combining software and hardware aspects. Furthermore,the present invention may take the form of carrier medium (e.g., acomputer program product on a computer-readable storage medium) carryingcomputer-readable program code embodied in the medium.

Carrier Medium:

The software may further be transmitted or received over a network via anetwork interface device. While the carrier medium is shown in anexample embodiment to be a single medium, the term “carrier medium”should be taken to include a single medium or multiple media (e.g., acentralized or distributed database, and/or associated caches andservers) that store the one or more sets of instructions. The term“carrier medium” shall also be taken to include any medium that iscapable of storing, encoding or carrying a set of instructions forexecution by one or more of the processors and that cause the one ormore processors to perform any one or more of the methodologies of thepresent invention. A carrier medium may take many forms, including butnot limited to, non-volatile media, volatile media, and transmissionmedia.

Implementation:

It will be understood that the steps of methods discussed are performedin one embodiment by an appropriate processor (or processors) of aprocessing (i.e., computer) system executing instructions(computer-readable code) stored in storage. It will also be understoodthat the invention is not limited to any particular implementation orprogramming technique and that the invention may be implemented usingany appropriate techniques for implementing the functionality describedherein. The invention is not limited to any particular programminglanguage or operating system.

Means for Carrying Out a Method or Function

Furthermore, some of the embodiments are described herein as a method orcombination of elements of a method that can be implemented by aprocessor of a processor device, computer system, or by other means ofcarrying out the function. Thus, a processor with the necessaryinstructions for carrying out such a method or element of a method formsa means for carrying out the method or element of a method. Furthermore,an element described herein of an apparatus embodiment is an example ofa means for carrying out the function performed by the element for thepurpose of carrying out the invention.

Connected

Similarly, it is to be noticed that the term connected, when used in theclaims, should not be interpreted as being limitative to directconnections only. Thus, the scope of the expression a device A connectedto a device B should not be limited to devices or systems wherein anoutput of device A is directly connected to an input of device B. Itmeans that there exists a path between an output of A and an input of Bwhich may be a path including other devices or means. “Connected” maymean that two or more elements are either in direct physical orelectrical contact, or that two or more elements are not in directcontact with each other but yet still co-operate or interact with eachother.

Embodiments

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment of the present invention. Thus, appearances of the phrases“in one embodiment” or “in an embodiment” in various places throughoutthis specification are not necessarily all referring to the sameembodiment, but may. Furthermore, the particular features, structures orcharacteristics may be combined in any suitable manner, as would beapparent to one of ordinary skill in the art from this disclosure, inone or more embodiments.

Similarly it should be appreciated that in the above description ofexample embodiments of the invention, various features of the inventionare sometimes grouped together in a single embodiment, figure, ordescription thereof for the purpose of streamlining the disclosure andaiding in the understanding of one or more of the various inventiveaspects. This method of disclosure, however, is not to be interpreted asreflecting an intention that the claimed invention requires morefeatures than are expressly recited in each claim. Rather, as thefollowing claims reflect, inventive aspects lie in less than allfeatures of a single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description of Specific Embodiments are herebyexpressly incorporated into this Detailed Description of SpecificEmbodiments, with each claim standing on its own as a separateembodiment of this invention.

Furthermore, while some embodiments described herein include some butnot other features included in other embodiments, combinations offeatures of different embodiments are meant to be within the scope ofthe invention, and form different embodiments, as would be understood bythose in the art. For example, in the following claims, any of theclaimed embodiments can be used in any combination.

Different Instances of Objects

As used herein, unless otherwise specified the use of the ordinaladjectives “first”, “second”, “third”, etc., to describe a commonobject, merely indicate that different instances of like objects arebeing referred to, and are not intended to imply that the objects sodescribed must be in a given sequence, either temporally, spatially, inranking, or in any other manner.

Specific Details

In the description provided herein, numerous specific details are setforth. However, it is understood that embodiments of the invention maybe practiced without these specific details. In other instances,well-known methods, structures and techniques have not been shown indetail in order not to obscure an understanding of this description.

Terminology

In describing the preferred embodiment of the invention illustrated inthe drawings, specific terminology will be resorted to for the sake ofclarity. However, the invention is not intended to be limited to thespecific terms so selected, and it is to be understood that eachspecific term includes all technical equivalents which operate in asimilar manner to accomplish a similar technical purpose. Terms such as“forward”, “rearward”, “radially”, “peripherally”, “upwardly”,“downwardly”, and the like are used as words of convenience to providereference points and are not to be construed as limiting terms.

Comprising and Including

In the claims which follow and in the preceding description of theinvention, except where the context requires otherwise due to expresslanguage or necessary implication, the word “comprise” or variationssuch as “comprises” or “comprising” are used in an inclusive sense, i.e.to specify the presence of the stated features but not to preclude thepresence or addition of further features in various embodiments of theinvention.

Any one of the terms: including or which includes or that includes asused herein is also an open term that also means including at least theelements/features that follow the term, but not excluding others. Thus,including is synonymous with and means comprising.

Scope of Invention

Thus, while there has been described what are believed to be thepreferred embodiments of the invention, those skilled in the art willrecognize that other and further modifications may be made theretowithout departing from the spirit of the invention, and it is intendedto claim all such changes and modifications as fall within the scope ofthe invention. For example, any formulas given above are merelyrepresentative of procedures that may be used. Functionality may beadded or deleted from the block diagrams and operations may beinterchanged among functional blocks. Steps may be added or deleted tomethods described within the scope of the present invention.

Although the invention has been described with reference to specificexamples, it will be appreciated by those skilled in the art that theinvention may be embodied in many other forms.

INDUSTRIAL APPLICABILITY

It is apparent from the above, that the arrangements described areapplicable to the healthcare medical device and medicalsoftware-as-a-service industries.

What is claimed is:
 1. A method for modelling the alignment of anorthopaedic implant for a joint of a patient, the method comprising thecomputer-implemented steps of: being responsive to patient specificinformation data for deriving patient data, the patient specificinformation data being indicative of one or more dynamiccharacteristics; and being responsive to the patient data for providing3D model data of the joint, such that the 3D model data shows theorthopaedic implant in an alignment configuration based on the patientspecific information data.
 2. A method as claimed in claim 1, whereinthe one or more dynamic characteristics comprise a virtual predictionbased on one or more of: joint kinematics data; joint loading data; andjoint articulation behaviour data during desired post-implantactivities.
 3. A method as claimed in claim 2, wherein the virtualprediction comprises a computer model prediction.
 4. A method as claimedin claim 1, wherein the patient specific information data is indicativeof one or more static characteristics.
 5. A method as claimed in claim4, wherein the one or more static characteristics comprises one or moreload bearing axes of a biomechanical reference frame.
 6. A method asclaimed in claim 5, wherein the one or more load bearing axes of thebiomechanical reference frame comprises a primary load bearing axis. 7.A method as claimed in claim 4, wherein the one or more staticcharacteristics comprise one or more load bearing axes of at least onereference frame of the group of biomechanical reference framescomprising: an acetabular reference frame, a femoral reference frame, atibial reference frame, and a spinal reference frame.
 8. A method asclaimed in claim 1, wherein the patient specific information datacomprises 2D imaging data.
 9. A method as claimed in claim 1, whereinthe patient specific information data comprises 3D imaging data.
 10. Amethod as claimed in claim 1, wherein the patient specific informationdata comprises 4D imaging data.
 11. A method as claimed in claim 1,wherein the patient specific information data comprises data beingindicative of one or more physical characteristics of the patient.
 12. Amethod as claimed in claim 11, wherein the one or more physicalcharacteristics comprises one or more of: age data, gender data, heightdata, weight data, activity level data, BMI data, body condition data,and body shape data.
 13. A method as claimed in claim 1, the methodfurther comprising the computer-implemented or non-computer-implementedsteps of: determining a set of possible alignment configurationsaccording to the patient data and patient acquired data, the patientacquired data being indicative of one or more desired post-implantactivities, the patient acquired data comprising post-implant activitiespreference data; and selecting an alignment configuration from the setof possible alignment configurations according to the post-implantactivities preference data.
 14. A method as claimed in claim 13, whereinthe post-implant activities preference data is a preference ratio beingindicative of comparative patient preference for the one or more desiredpost-implant activities.
 15. A method as claimed in claim 13, the methodfurther comprising the computer-implemented or non-computer-implementedstep of: accessing a database of library alignment configuration data,wherein the alignment configuration is further selected according to thelibrary alignment configuration data.
 16. A method as claimed in claim15, wherein the library alignment configuration data comprises datarelating to a group of available orthopaedic implants for performing atleast one of the one or more desired post-implant activities.
 17. Amethod as claimed in claim 15, wherein the library alignmentconfiguration data comprises data relating to a group of patients fittedwith an orthopaedic implant for performing at least one of the one ormore desired post-implant activities.
 18. A computing device formodelling the alignment of an orthopaedic implant for a joint of apatient, the computing device comprising: a processor for processingdigital data; a memory device for storing digital data includingcomputer program code and being coupled to the processor via a bus; anda data interface for sending and receiving digital data and beingcoupled to the processor via the bus, wherein the processor iscontrolled by the computer program code to: receive, via the datainterface, patient specific information data for deriving patient data,the patient specific information data being indicative of one or moredynamic characteristics; calculate patient data according to the patientspecific information data; and calculate 3D model data of the jointaccording to the patient data, such that the 3D model data shows theorthopaedic implant in an alignment configuration.
 19. A computingdevice as claimed in claim 18, wherein the one or more dynamiccharacteristics comprise a virtual prediction based on one or more of:joint kinematics data; joint loading data; and joint articulationbehaviour data during desired post-implant activities.
 20. A computingdevice as claimed in claim 19, wherein the virtual prediction comprisesa computer model prediction.
 21. A computing device as claimed in claim18, wherein the patient specific information data is indicative of oneor more static characteristics.
 22. A computing device as claimed inclaim 21, wherein the one or more static characteristics comprises oneor more load bearing axes of a biomechanical reference frame.
 23. Acomputing device as claimed in claim 22, wherein the one or more loadbearing axes of the biomechanical reference frame comprises a primaryload bearing axis.
 24. A computing device as claimed in claim 21,wherein the one or more static characteristics comprise one or more loadbearing axes of at least one reference frame of the group ofbiomechanical reference frames comprising: an acetabular referenceframe, a femoral reference frame, a tibial reference frame, and a spinalreference frame.
 25. A computing device as claimed in claim 18, whereinthe patient specific information data comprises data being indicative ofone or more physical characteristics of the patient.
 26. A computingdevice as claimed in claim 25, wherein the one or more physicalcharacteristics comprises one or more of: age data, gender data, heightdata, weight data, activity level data, BMI data, body condition data,and body shape data.
 27. A computing device as claimed in claim 18,wherein the processor is further controlled by the computer program codeto: receive, via the data interface, patient acquired data beingindicative of one or more desired post-implant activities, the patientacquired data comprising post-implant activities preference data;calculate a set of possible alignment configurations according to thepatient data and the patient acquired data; and select an alignmentconfiguration from the set of possible alignment configurationsaccording to the post-implant activities preference data.
 28. Acomputing device as claimed in claim 27, wherein the post-implantactivities preference data is a preference ratio being indicative ofcomparative patient preference for the one or more desired post-implantactivities.
 29. A computing device as claimed in claim 27, furthercomprising a database for storing digital data including libraryalignment configuration data, the database being coupled to theprocessor, wherein the processor is further controlled by the computerprogram code to: load from the database, the library alignmentconfiguration data, wherein the alignment configuration is furtherselected according to the library alignment configuration data.
 30. Acomputing device as claimed in claim 29, wherein the library alignmentconfiguration data comprises data relating to a group of availableorthopaedic implants for performing at least one of the one or moredesired post-implant activities.
 31. A computing device as claimed inclaim 29, wherein the library alignment configuration data comprisesdata relating to a group of patients fitted with an orthopaedic implantfor performing at least one of the one or more desired post-implantactivities.
 32. A computer readable storage medium comprising computerprogram code instructions, being executable by a computer, for:receiving, via a data interface, patient specific information data forderiving patient data, the patient specific information being indicativeof one or more dynamic characteristics; calculating patient dataaccording to the patient specific information data; and calculating 3Dmodel data of a joint according to the patient data, such that the 3Dmodel data shows an orthopaedic implant in an alignment configuration.33. A computer readable storage medium as claimed in claim 32, whereinthe one or more dynamic characteristics comprise a virtual predictionbased on one or more of: joint kinematics data; joint loading data; andjoint articulation behaviour data during desired post-implantactivities.
 34. A computer readable storage medium as claimed in claim33, wherein the virtual prediction comprises a computer modelprediction.
 35. A computer readable storage medium as claimed in claim32, further comprising instructions for: receiving, via the datainterface, patient acquired data being indicative of one or more desiredpost-implant activities, the patient acquired data comprisingpost-implant activities preference data; calculating a set of possiblealignment configurations according to the patient data and the patientacquired data; and selecting an alignment configuration from the set ofpossible alignment configurations according to the post-implantactivities preference data.
 36. A computer readable storage medium asclaimed in claim 35, wherein the post-implant activities preference datais a preference ratio being indicative of comparative patient preferencefor the one or more desired post-implant activities.
 37. A clientcomputing device comprising an interface for sending and receivingdigital data and being coupled, across a data link, to a computingdevice as claimed in any one of claims 18 to 31, wherein the interfaceis adapted for sending and receiving digital data as referred to in anyone of claims 18 to 31.